Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2080225

FEI Number

2080225

Entity Name

KENTEC MEDICAL, INC.

City/State/Country

Irvine, CA, US

Establishment Address

17871 FITCH, Irvine, CA 92614, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

KENTEC MEDICAL, INC. (Owner Number: 2080225)

Owner / Operator Contact Address

17871 FITCH, --, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK000008

PMA Number

N/A

All Registered Proprietary Names

HAVE A HEART ELECTRODE Accutemp(r) PROBE COVER RadTag Gamma indicator Hummi Micro Draw Ameritus Oral Syringe(GB), Ameritus push-in Bottle Adapter(GB) Ameritus ENFit enteral feeding tube(vr) Swab-eze Ameritus Entral(tm) Feeding Tube Ameritus Enteral Extension Set ACCU-BOARD Ameritus(R) Milk Straw Ameritus ENFit(r) Enteral Syringes RadTag x-ray indicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2006-02-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2006-02-07
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2014-10-22
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2012-05-16
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2020-06-01
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2020-07-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-07-28
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2020-07-28
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-06-18
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2010-06-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-03-05
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2006-02-07
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2013-12-31
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-10-05
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2014-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KENTEC MEDICAL, INC.

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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

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3013522941	JOHNSON MEDTECH LLC	Vandalia, OH, US
3013873578	SHANGHAI YUECHEN MEDICAL SUPPLY CO..LTD.	Shanghai, CN
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
3008773647	CARDIONET, LLC	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2080225. Last updated year: 2026. Please use registration number 2080225 when referencing this establishment in official correspondence.