Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004551550

FEI Number

3004551550

Entity Name

TYTEK MEDICAL INC

City/State/Country

West Chester, OH, US

Establishment Address

8904 Beckett Rd., West Chester, OH 45069, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TyTek Medical Inc (Owner Number: 10035776)

Owner / Operator Contact Address

8904 Beckett Rd., West Chester, OH 45069, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical HypoHolder Clinical HypoHolder TM-512 Xtricate Lyte Individual Stretcher TM-212 Abdominal Trauma Bandage TM-206 6" Trauma Bandage TM-204 4" Trauma Bandage 1010TMS Wolf Trauma Bandage 4"; 1020 TMS Tiger Trauma Bandage 6"; 1030TMS Bear Multi-Wound Bandage PneumoDart Tpak Tapk 10 DART PDF185 TMT Tourniquet; PDF186 TMT Tourniquet; PDF187 TMT Tourniquet TM-707 Large Piranha Trauma Shears TM-705 Small Piranha Trauma Shears HypoFoam HypoPan Crico Tube Ptensys Bleeding Control Station Enhanced, TM-405 Ptensys Bleeding Control Station, TM-400 Ptensys Bleeding Control Kit, TM-401 Ptensys Bleeding Control Kits Enhanced, TM-406 Ptensys Individual Bleeding Control Kit Ultimate, TM-412 Ptensys Bleeding Control Pouch, TM-403 Ptensys Bleeding Control Station Ultimate, TM-409 Ptensys Bleeding Control Pouch Enhanced, TM-407 Ptensys Bleeding Control Kits Ultimate, TM-410 Ptensys Individual Bleeding Control Kit, TM-404 Ptensys Bleeding Control Pouch Ultimate, TM-411 Ptensys Individual Bleeding Control Kits Enhanced, TM-408 TM-215 EZ Gauze

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-05-08
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2022-11-11
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2011-03-23
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2011-03-23
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-12-14
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2022-11-07
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-06-10
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-04-16
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2014-11-10
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-09-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-03-23

Official Correspondent

Chris Tyler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TyTek 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

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3001614464	medi-G GMBH	Messkirch Baden-Wurttemberg, DE
3028006458	ClearPoint Neuro Inc.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004551550. Last updated year: 2026. Please use registration number 3004551550 when referencing this establishment in official correspondence.