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

LRS — Predicate Candidate Screening

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

72 daysmedian FDA review time

337 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050654	AMSINO I.V. START KIT	Amsino International, Inc.	2005-05-02	49	0
K001879	INFUSION IV SET	Nirvi Intl. USA	2001-11-20	518	0
K963722	IV START KIT	Grand Medical Products	1996-11-27	72	0
K951167	EMS I.V. START KIT	Emergency Medical Supply, Inc.	1995-05-16	63	0
K950184	B. BRAUN IV START KITS	B. Braun of America, Inc.	1995-03-15	57	0
K944041	PERSONAL HEARING SYSTEM	Resound Corp.	1994-12-27	131	0
K943941	SAFESTART VASCULAR ACCESS START KIT	Becton Dickinson Vascular Access, Inc.	1994-10-20	69	0
K935684	IV START KIT	Cush Medical Products	1994-06-10	193	0
K942238	I.V. STARTPAK VASCULAR ACCESS START KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994-06-03	25	0
K941469	IV START KIT	Clinical Resources, Inc.	1994-05-12	45	0
K925017	IV PREP KIT (NON-STERILE)	Customed, Inc.	1993-08-27	337	0
K925018	IV PREP KIT W/O DRESSING (NON-STERILE)	Customed, Inc.	1993-08-27	337	0
K933041	COLD CD ASP MODULE, ITE	Electone, Inc.	1993-08-02	96	0
K930196	CEPTI-SEAL I.V. PREP KIT	Medi-Flex Hospital Products, Inc.	1993-07-02	169	0
K924538	IV START KIT	Cml, Inc.	1993-07-02	297	0
K923361	I.V. START KIT, STERILE, DISPOSABLE	Trinity Laboratories, Inc.	1993-06-28	355	0
K924811	I.V. START KIT	Transidyne General Corp.	1993-06-17	265	0
K926031	PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT	Brigam Medical, Inc.	1993-06-07	188	0
K922533	IV START KIT CUSTOM SMP # A-Z	Specialty Medical Products Co.	1993-03-23	299	0
K914475	IV START KIT	Cypress Medical Products, Ltd.	1992-03-18	162	0
K875315	I.V. START KITS	Ni-Med, Inc.	1988-02-17	50	0
K871731	TELSTAR PREWIRE SERIES	Telstar Electronics, Inc.	1987-10-27	175	0
K871281	IV START KIT	The Jarid Group, Inc.	1987-05-27	57	0
K863796	CREATIVE CARE SYSTEMS' IV START KIT	American Biomaterials Corp.	1986-11-28	60	0
K863712	I.V. START KIT, STERILE, DISPOSABLES	Busse Hospital Disposables, Inc.	1986-10-22	29	0
K852375	I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE	Ferris Mfg. Corp.	1985-07-11	37	0
K844614	IV START KIT	Packaging Technologies, Inc.	1984-12-19	22	0
K842898	CURITY I.V. START KIT	The Kendal Co.	1984-08-17	25	1
K820490	IV START TRAY	Seamless Hospital Products Co.	1982-03-16	21	0
K760876	ARGYLE IV STARTER KIT (W/O DRUG)	Sherwood Medical Industries	1976-12-09	66	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