Trinity Laboratories, Inc.

Raleigh, NC, US

Trinity Laboratories, Inc. appears in FDA device records in Raleigh, NC. FDA records list 44 510(k) clearances between 1990-06-28 and 1998-07-10, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 44
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 44 510(k) clearances for Trinity Laboratories, Inc. between 1990 and 1998. The busiest year on record is 1992, with 18. The most recent is 1998, with 2.

Clearances by year, as a table

510(k) clearance decisions for Trinity Laboratories, Inc., by decision year
Year	Clearances
1990	1
1992	18
1993	5
1994	6
1995	7
1997	5
1998	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K981441	HEART CATH TRAY, STERILE, DISPOSABLE	DQO	Substantially Equivalent	1998-07-10
K974238	DENTAL TRAY, STERILE, DISPOSABLE	EIA	Substantially Equivalent	1998-02-04
K974286	CIRCUMCISION TRAY, CAT. NO. 70340	HFX	Substantially Equivalent	1997-12-12
K972160	CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST	DCK	Substantially Equivalent	1997-08-01
K970722	EYE TRAY	KKX	Substantially Equivalent	1997-03-31
K965201	O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE	LRO	Unknown	1997-02-14
K964921	BASIC BIOPSY TRAY. DISPOSABLE, STERILE	LRO	Substantially Equivalent	1997-01-22
K953929	MID-STREAM COLLECTION SET-STERILE	LIO	Substantially Equivalent	1995-11-16
K952058	STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE	FOZ	Substantially Equivalent	1995-09-21
K953070	WOUNDFOAM 4 X 4	KMF	Substantially Equivalent	1995-09-08
K951506	SUCTION CATHETER KIT, STERILE, SINGLE-USE	BSY	Substantially Equivalent	1995-07-03
K951479	CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE	FCM	Substantially Equivalent	1995-06-15
K951443	STANDARD FOLEY SYSTEM PAK	FCN	Substantially Equivalent	1995-06-15
K945671	CONTINUOUS EPIDURAL ANESTHESIA TRAY	CAZ	Unknown	1995-02-16
K942221	IRRIGATION TRAY WITH PISTON SYRINGE	FMF	Unknown	1994-08-05
K941999	HYPERTONIC SALINE WET DRESSING - STERILE	KMF	Substantially Equivalent for Some Indications	1994-06-29
K942014	STERILE WATER WET DRESSING	MGF	Substantially Equivalent	1994-05-27
K933526	STERILE WATER	JOL	Substantially Equivalent	1994-03-10
K934750	YANKAUER WITH CONNECTING TUBING	GCJ	Substantially Equivalent	1994-02-17
K930418	CRYPTO-LEX SYSTEM	GMD	Substantially Equivalent	1994-02-17
K934258	SALINE WET DRESSING- STERILE	FRO	Substantially Equivalent	1993-11-24
K933412	SALINE SOLUTION-STERILE	JOH	Substantially Equivalent	1993-10-01
K926173	STAPH-A-LEX(TM) SYSTEM	JWX	Substantially Equivalent	1993-08-10
K923361	I.V. START KIT, STERILE, DISPOSABLE	LRS	Unknown	1993-06-28
K920346	VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL	KKX	Substantially Equivalent	1993-03-03
K915320	RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST	DHR	Substantially Equivalent	1992-12-07
K920284	DRAPE UTILITY/SURGICAL STERILE DISPOSABLE	KKX	Substantially Equivalent	1992-10-19
K921490	DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP	FRG	Unknown	1992-10-05
K923098	STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE	BSY	Substantially Equivalent	1992-09-21
K920846	CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER	FXX	Unknown	1992-09-01
K921281	TRACHEOSTOMY CARE KIT	BTO	Unknown	1992-08-27
K920281	TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE	BTO	Unknown	1992-08-27
K920518	E.R. SUTURE TRAY, STERILE, DISPOSABLE	KKX	Unknown	1992-08-17
K921394	DRESSING CHANGE TRAY, STERILE, DISPOSABLE	KKX	Unknown	1992-08-13
K921204	DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE	KKX	Unknown	1992-08-13
K921203	INCISSION & DRAINAGE TRAY	KKX	Unknown	1992-08-13
K922033	SALINE SOLUTION- STERILE	CCQ	Substantially Equivalent	1992-07-21
K920282	PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE	NAB	Substantially Equivalent	1992-05-29
K920283	DISPOSABLE SKIN STAPLE REMOVER	MCZ	Substantially Equivalent	1992-05-22
K920517	MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP	KKX	Unknown	1992-05-11
K920280	SUTURE REMOVAL KIT, STERILE, DISPOSABLE	MCZ	Unknown	1992-05-11
K921464	CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT	GBQ	Substantially Equivalent	1992-05-05
K920516	GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB	KDD	Unknown	1992-04-16
K902541	MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX	KTN	Substantially Equivalent	1990-06-28

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain