Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031525

FEI Number

6827

Entity Name

KAI INDUSTRIES CO., LTD.

City/State/Country

SEKI CITY Gifu, JP

Establishment Address

1110 OYANA, SEKI CITY Gifu 501-3992, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KAI INDUSTRIES CO., LTD. (Owner Number: 8031525)

Owner / Operator Contact Address

1110 Oyana, Seki, JP-21 5013992, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RNU-52AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.2MM ANTI-GLARE TYPE VK-19GF MVR 19 GAUGE VITRECTOMY KNIFE dia. 1MM SP-S15 ANGLE 15 DEGREE WIDTH 1MM THICKNESS 0.1MM BKB-10AGF BEVEL UP, 45 DEGREE BENT WIDTH 1MM ANTI-GLARE TYPE ST30 ANGLE 30 DEGREE THICKNESS 0.12MM SK-SLU20 MBEVEL UP, 45 DEGREE BENT WIDTH 2MM CCR-28AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM ANTI-GLARE TYPE CCR-30AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM ANTI-GLARE TYPE A-15F ANGLE 15 DEGREE THICKNESS 0.1MM SK-CPU26 BEVEL UP, 45 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE CCR-32AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3.2MM ANTI-GLARE TYPE A-30F ANGLE 30 DEGREE THICKNESS 0.1MM SLU-25AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.5MM ANTI-GLARE TYPE SK-CCR20 MDOUBLE BEVEL, 45 DEGREE BENT WIDTH 2MM CCR-24AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM ANTI-GLARE TYPE RNU-56AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.6MM ANTI-GLARE TYPE SK-CCR30 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM SLU-285AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.85MM ANTI-GLARE TYPE SK-CPU16 BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE TR-15/19AGF BEVEL UP, 45 DEGREE BENT 1.5x1.9 ANTI-GLARE TYPE CCR-20AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2MM ANTI-GLARE TYPE CCR-23AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.3MM ANTI-GLARE TYPE SLU-30AGF BEVEL UP, 45 DEGREE BENT WIDTH 3MM ANTI-GLARE TYPE SLU-265AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.65MM ANTI-GLARE TYPE SK-A225 ANGLE 22.5 DEGREE THICKNESS 0.1MM PCB-10AGF ANGLED 1MM WIDTH THICKNESS 0.1MM SK-VKB20G MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM BENT TYPE SK-CCR32 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3.2MM SK-SLU22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM A-45F ANGLE 45 DEGREE THICKNESS 0.1MM ST15 ANGLE 15 DEGREE THICKNESS 0.12MM CCR-25AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.5MM ANTI-GLARE TYPE CC28 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM SK-SLU28 BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM SLU-13AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.3MM ANTI-GLARE TYPE SL275 BEVEL UP, 45 DEGREE BENT WIDTH 2.75MM SLU-15AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.5MM ANTI-GLARE TYPE CC275 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.75MM SLU-16AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE SK-SLU18 MBEVEL UP, 45 DEGREE BENT WIDTH 1.8MM SLU-24AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM ANTI-GLARE TYPE SLU-32AGF BEVEL UP, 45 DEGREE BENT WIDTH 3.2MM ANTI-GLARE TYPE CPU-26AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE SLU-19AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.9MM ANTI-GLARE TYPE SLU-20AGF BEVEL UP, 45 DEGREE BENT WIDTH 2MM ANTI-GLARE TYPE SL22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM SP-U10 BEVEL UP, 45 DEGREE BENT WIDTH 1MM ANTI-GLARE TYPE SLU-22AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE VK-20GF MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM RNU-51AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.1MM ANTI-GLARE TYPE CCR-265AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.65MM ANTI-GLARE TYPE BKS-10AGF BEVEL UP, STRAIGHT WIDTH 1MM ANTI-GLARE TYPE ST225 ANGLE 22.5 DEGREE THICKNESS 0.12MM SK-CPU22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE SL24 BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM CPU-16AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE VKB-20GF MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM BENT TYPE SK-A15 ANGLE 15 DEGREE THICKNESS 0.1MM SK-SLU30 BEVEL UP, 45 DEGREE BENT WIDTH 3MM SP-T12 BEVEL UP, 30 DEGREE BENT 0.5x1.2 ANTI-GLARE TYPE VK25 MVR 25 GAUGE VITRECTOMY KNIFE dia. 0.5MM SLU-14AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.4MM ANTI-GLARE TYPE CC24 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM CCR-18AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 1.8MM ANTI-GLARE TYPE SK-SLU23 BEVEL UP, 45 DEGREE BENT WIDTH 2.3MM SK-CCR22 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM CC22 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM CCR-22AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE TR-125/14AGF BEVEL UP, 45 DEGREE BENT 1.25x1.4 ANTI-GLARE TYPE SLU-275AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.75MM ANTI-GLARE TYPE SK-A30 ANGLE 30 DEGREE THICKNESS 0.1MM SK-CCR18 MDOUBLE BEVEL, 45 DEGREE BENT WIDTH 1.8MM PCT-10F STRAIGHT 1MM WIDTH THICKNESS 0.1MM CPU-22AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE SK-CCR24 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM SL30 BEVEL UP, 45 DEGREE BENT WIDTH 3MM A-0F ANGLE 0 DEGREE THICKNESS 0.1MM VK23 MVR 23 GAUGE VITRECTOMY KNIFE dia. 0.6MM CC30 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM SLU-23AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.3MM ANTI-GLARE TYPE SLU-18AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.8MM ANTI-GLARE TYPE TR-12/14AGF BEVEL UP, 45 DEGREE BENT 1.2x1.4 ANTI-GLARE TYPE SLU-17AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.7MM ANTI-GLARE TYPE VK-23GF MVR 23 GAUGE VITRECTOMY KNIFE dia. 0.6MM SK-SLU24 BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM A-225F ANGLE 22.5 DEGREE THICKNESS 0.1MM SK-CCR28 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM VK20 MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM RNU-41AGF BEVEL UP, 45 DEGREE BENT WIDTH 4.1MM ANTI-GLARE TYPE SK-CCR23 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.3MM SLU-28AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM ANTI-GLARE TYPE SL28 BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM CWU-26AGF BEVEL UP, 60 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE SK-SLU32 BEVEL UP, 45 DEGREE BENT WIDTH 3.2MM HANDLE, SCALPEL PLASTIC KNIFE HANDLE STYLE NO.3 PLASTIC KNIFE HANDLE STYLE NO.4 CURETTE, SURGICAL, GENERAL USE DERMAL CURETTE 4MM DERMAL CURETTE 3MM DERMAL CURETTE 2MM DERMAL CURETTE 7MM DERMAL CURETTE 5MM Microtome Blade; HP35 Coated, HP35 Ultra, MB22 Premier, MB35 Premier, MX35 Premier, MX35 Premier+, MX35 Ultra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-12-07
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-10-07
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-11-04
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2001-11-08
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2001-11-08
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2017-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

Noritaka Sawamura Business: KAI USA LTD. Email: nsawamura@kai-usa.com Phone: (503) 6821966

Related Public Records

Same Entity

KAI INDUSTRIES CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
8010298	RUDOLF MEDICAL GMBH + CO. KG	FRIDINGEN Baden-Wurttemberg, DE
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
8040373	NADEEM SURGICAL CORP. PRIVATE LTD.	SIALKOT Punjab, PK
2531475	URAMIX, INC.	E Lansdowne, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031525. Last updated year: 2026. Please use registration number 8031525 when referencing this establishment in official correspondence.