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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Trinity Laboratories, Inc. — Predicate Candidate Screening

44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time
271 days90th percentile
44clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981441HEART CATH TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.1998-07-10800
K974238DENTAL TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.1998-02-04840
K974286CIRCUMCISION TRAY, CAT. NO. 70340Trinity Laboratories, Inc.1997-12-12280
K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUTrinity Laboratories, Inc.1997-08-01530
K970722EYE TRAYTrinity Laboratories, Inc.1997-03-31320
K965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.1997-02-14500
K964921BASIC BIOPSY TRAY. DISPOSABLE, STERILETrinity Laboratories, Inc.1997-01-22440
K953929MID-STREAM COLLECTION SET-STERILETrinity Laboratories, Inc.1995-11-16870
K952058STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSATrinity Laboratories, Inc.1995-09-211420
K953070WOUNDFOAM 4 X 4Trinity Laboratories, Inc.1995-09-08700
K951506SUCTION CATHETER KIT, STERILE, SINGLE-USETrinity Laboratories, Inc.1995-07-03910
K951479CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABTrinity Laboratories, Inc.1995-06-15770
K951443STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.1995-06-15780
K945671CONTINUOUS EPIDURAL ANESTHESIA TRAYTrinity Laboratories, Inc.1995-02-16900
K942221IRRIGATION TRAY WITH PISTON SYRINGETrinity Laboratories, Inc.1994-08-05910
K941999HYPERTONIC SALINE WET DRESSING - STERILETrinity Laboratories, Inc.1994-06-29650
K942014STERILE WATER WET DRESSINGTrinity Laboratories, Inc.1994-05-27310
K933526STERILE WATERTrinity Laboratories, Inc.1994-03-102320
K930418CRYPTO-LEX SYSTEMTrinity Laboratories, Inc.1994-02-173870
K934750YANKAUER WITH CONNECTING TUBINGTrinity Laboratories, Inc.1994-02-171360
K934258SALINE WET DRESSING- STERILETrinity Laboratories, Inc.1993-11-24850
K933412SALINE SOLUTION-STERILETrinity Laboratories, Inc.1993-10-01800
K926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.1993-08-102450
K923361I.V. START KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.1993-06-283550
K920346VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABLTrinity Laboratories, Inc.1993-03-034010
K915320RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TESTTrinity Laboratories, Inc.1992-12-073810
K920284DRAPE UTILITY/SURGICAL STERILE DISPOSABLETrinity Laboratories, Inc.1992-10-192710
K921490DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISPTrinity Laboratories, Inc.1992-10-051890
K923098STERILE MUCOUS SPECIMEN TRAP, DISPOSABLETrinity Laboratories, Inc.1992-09-21880
K920846CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STERTrinity Laboratories, Inc.1992-09-011890
K920281TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.1992-08-272180
K921281TRACHEOSTOMY CARE KITTrinity Laboratories, Inc.1992-08-271630
K920518E.R. SUTURE TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.1992-08-171950
K921204DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.1992-08-131540
K921394DRESSING CHANGE TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.1992-08-131430
K921203INCISSION & DRAINAGE TRAYTrinity Laboratories, Inc.1992-08-131540
K922033SALINE SOLUTION- STERILETrinity Laboratories, Inc.1992-07-21810
K920282PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLETrinity Laboratories, Inc.1992-05-291280
K920283DISPOSABLE SKIN STAPLE REMOVERTrinity Laboratories, Inc.1992-05-221210
K920517MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISPTrinity Laboratories, Inc.1992-05-11970
K920280SUTURE REMOVAL KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.1992-05-111100
K921464CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INTTrinity Laboratories, Inc.1992-05-05390
K920516GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSABTrinity Laboratories, Inc.1992-04-16720
K902541MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEXTrinity Laboratories, Inc.1990-06-28220

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda