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

LRO — Predicate Candidate Screening

110 FDA 510(k) clearances under this product code; the 50 most recent screened below.

79 daysmedian FDA review time

302 days90th percentile

110clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K213481	Medline General Surgery Tray	Medline Industries, Inc.	2022-05-24	207	39
K212258	Medline Cardiovascular Procedure Kit	Medline Industries, Inc.	2021-12-03	136	0
K041080	SURGICAL DRAPE KIT - D.I.R.R.A. SRL	D.I.R.R.A. S.R.L.	2004-11-30	218	0
K030721	QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE	Ballard Medical Products	2003-03-31	24	0
K023276	AMSINO TRACHEOSTOMY CARE TRAY	Amsino International, Inc.	2002-12-09	69	0
K980137	WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE	Worldwide Medical Technologies, LLC	1998-01-30	15	0
K971061	OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY	Opportunity, Inc.	1997-06-11	79	0
K971062	OPPORTUNITY INC. GENERAL PURPOSE TRAY	Opportunity, Inc.	1997-06-09	77	0
K932221	NEUROLOGICAL OR CRANI TRAYS (PACKS)	Associated Medical Products Co.	1997-03-19	1412	0
K970286	PRESBYTERIAN LINEN SERVICES SURGICAL PACKS	Medline Industries, Inc.	1997-03-10	45	0
K965201	O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE	Trinity Laboratories, Inc.	1997-02-14	50	0
K970187	RUNYON LARGE VOLUME PARACENTESIS KIT	Gi Supply	1997-02-14	28	0
K964921	BASIC BIOPSY TRAY. DISPOSABLE, STERILE	Trinity Laboratories, Inc.	1997-01-22	44	0
K963715	DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY	Grand Medical Products	1996-11-27	72	0
K963721	SKIN SCRUB TRAY	Grand Medical Products	1996-11-27	72	0
K964011	SUCTION CATHETER TRAY PRODUCT NO. 900277	Customed, Inc.	1996-11-25	49	1
K963443	PROD. NO. 02-031 - LACERATION TRAY	Continental Medical Laboratories, Inc.	1996-10-17	48	0
K962826	MEDLINE RADIOLOGY-DIAGNOSTIC KITS	Medline Industries, Inc.	1996-09-16	59	3
K961863	PARACENTESIS TRAYS	Tri-Med, Inc.	1996-05-28	14	0
K953083	HOSPITAL LAUNDRY SERVICES SURGICAL PACKS	Hospital Laundry Services	1996-05-14	316	0
K961683	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	J.J. Skinner, Inc.	1996-05-10	9	0
K952539	RADIOLOGY PACKS	Sterile Concepts, Inc.	1995-07-14	44	0
K951478	GENERAL AND PLASTIC SURGERY PACKS	Sterile Concepts, Inc.	1995-06-13	75	0
K950295	WOUND CLOSURE/LACERATION TRAY	Customed, Inc.	1995-04-18	84	14
K951149	SINGLE USE INSTRUMENT TRAY	Medcare Custom Packaging, Inc.	1995-04-06	24	0
K950574	NEEDLE/CANNULA	Tri-Med Specialties, Inc.	1995-02-24	28	0
K945831	DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT	Micromed Development Corp.	1995-01-20	52	0
K945481	SHAVE PREP KIT	Harding Industries, Inc.	1994-12-23	45	0
K945160	PARACENTESIS NEEDLES/CANNULAS	Tri-Med Specialties, Inc.	1994-11-14	24	0
K944044	CHIBA STYLE BIOPSY NEEDLE	Kormed, Inc.	1994-10-03	46	0
K941846	BONE MARROW BIOPSY TRAY	Kormed, Inc.	1994-05-18	34	0
K925467	JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT	J.J. Skinner, Inc.	1994-05-11	559	0
K934688	STERILE DESIGN	Sterile Design, Inc.	1994-03-16	167	0
K935743	INSTRUMENT TRAY	Cush Medical Products	1994-03-03	92	0
K936117	CENTRAL LINE TRAY	Cush Medical Products	1994-03-01	68	0
K935686	DRESSING CHANGE TRAY	Cush Medical Products	1994-02-25	88	0
K933137	ACU-SUTURE KIT	Acuderm, Inc.	1994-02-22	239	0
K935858	MILL-ROSE PERCUTANEOUS PROCEDURAL KIT	Mill-Rose Laboratory	1994-02-22	76	0
K935740	IRRIGATION TRAY	Cush Medical Products	1994-02-22	83	0
K930270	PATIENT PREOPERATIVE PREP TRAY, SINGLE USE	Professional Medical Products, Inc.	1994-02-17	394	0
K934028	STERILE DRESSING CHANGE TRAY	Surgipro, Inc.	1994-02-17	184	0
K935741	O.R. BASIN SET TRAY	Cush Medical Products	1994-02-15	76	0
K935483	E-Z PREP(R) TRAY WITH HIBICLENS(R)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994-02-09	86	0
K931820	CARAPACE STILLWATER BOWL SET	Carapace, Inc.	1994-02-07	305	0
K931760	CARAPACE PACKING GAUZE TRAYS	Carapace, Inc.	1994-02-04	302	0
K934029	STERILE LACERATION & DEBRIDEMENT TRAYS	Surgipro, Inc.	1994-02-04	171	0
K931758	CARAPACE WOUND DRESSING KITS & LACERATION TRAYS	Carapace, Inc.	1994-01-26	293	0
K920292	VARIOUS KITS AND TRAYS	Professional Medical Products, Inc.	1994-01-26	735	0
K934030	STERILE TRACHEOSTOMY TRAY	Surgipro, Inc.	1994-01-26	162	0
K931759	CARAPACE STERILE GAUZE TRAYS	Carapace, Inc.	1994-01-25	292	0

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