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

KNY — Predicate Candidate Screening

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

78 daysmedian FDA review time

207 days90th percentile

65clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260919	Transurethral Catheter Safety Valve (TUCSV) (80050)	Class Medical , Ltd.	2026-08-05	139	0
K182144	Bi-Flex Evo	Promepla Sam	2018-09-07	30	0
K162356	Vesair Cystoscopic Sheath	Solace Therapeutics	2017-03-02	191	0
K140441	BI-FLEX URETERAL ACCESS SHEATH	Promepla Sam	2014-06-17	116	0
K140562	WIJAY EZ-VOID EXTERNAL CATHETER VALVE	Leomed, LLC	2014-06-16	103	0
K141252	GUARDIAN URETHRAL SHEATH	Solace Therapeutics	2014-06-09	26	0
K131803	GUARDIAN URETHRAL SHEATH	Solace Therapeutics	2013-08-20	62	0
K123170	VARI-PASS VARIABLE LENGTH ACCESS SHEATH	Olympus Surgical Technologies America	2013-02-04	118	0
K120160	ROCAMED ROCAUS PLATINUM	Promepla Sam	2012-05-14	116	0
K112209	PREFILLED CATHETER INFLATION SYRINGE	Avail Medical Products, Inc.	2011-09-08	38	0
K090121	PRE-FILLED CATHETER INFLATION SYRINGE	Avail Medical Products, Inc.	2009-04-15	84	0
K052298	CYSTOGLIDE INTRODUCER SHEATH	Percutaneous Systems, Incorporated	2006-12-12	476	0
K062240	CAREVENT	Chief Medical, LLC	2006-10-16	75	0
K052952	CATHASSIST	Physician Technologies, Inc.	2006-05-14	206	0
K052134	CYSTOGLIDE DILATING INTRODUCER SHEATH	Percutaneous Systems, Inc.	2005-09-22	48	0
K051593	UROPASS URETERAL ACCESS SHEATH, MODEL 61224	Acmi Corporation	2005-09-02	78	2
K042531	UPDATED SLIP UROLOGY INTRODUCER SHEATH	Percutaneous Systems, Incorporated	2005-02-01	137	0
K042877	MICROVERTER URETERAL ACCESS SHEATH	Percutaneous Systems, Inc.	2004-11-16	29	0
K040520	SLIP UROLOGY INTRODUCER SHEATH	Percutaneous Systems, Inc.	2004-05-20	83	0
K032127	HEMEDEX FIXATION DEVICE	Hemedex Incorporated	2003-12-30	173	0
K023690	CATHETER CONNECTOR	World Metals, Inc.	2003-02-28	119	0
K000767	MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201	Memcath Technologies, LLC	2000-06-05	88	0
K991097	PBN DRAINAGE CATHETER GUIDEWIRES	Medical Device Technologies, Inc.	1999-04-23	22	0
K981611	SNAP-N-PEEL INTRODUCERS	Circon Corp.	1998-07-30	85	0
K981667	HYDROPHILIC COATED GUIDEWIRE	Lake Region Mfg., Inc.	1998-06-05	25	0
K981229	MANAN MANTA CATHETER FIXATION DISK	Medical Device Technologies, Inc.	1998-04-22	19	0
K972977	INSULATOR WIRE GUIDE	Cook Urological, Inc.	1997-10-10	60	0
K960866	LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KI	Lake Region Mfg., Inc.	1996-04-05	32	0
K954132	MANAN MANTA CATHETER FIXATION DISK	Manan Medical Products, Inc.	1996-03-26	207	0
K952414	PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER	Acacia Laboratories, Inc.	1995-06-23	31	0
K951995	KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR	Karl Storz Endoskop GmbH	1995-05-24	26	0
K951488	KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP	The Kendal Co.	1995-04-25	25	0
K943835	PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID	Orion Life Systems, Inc.	1995-01-24	172	0
K944754	AMPLATZ SUPER STIFF GUIDEWIRE	Boston Scientific Corp	1994-10-07	11	0
K944135	UROLOGICAL GUIDWIRE	Applied Medical Resources	1994-09-21	28	0
K934072	CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM	Contour Fabricators of Florida, Inc.	1994-09-08	384	0
K942205	ZEBRA UROLOGICAL GUIDEWIRE	Boston Scientific Corp	1994-07-07	63	0
K942074	FLEXFINDER GUIDEWIRE	Flexmedics	1994-06-24	56	0
K935643	SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE	Regulatory & Marketing Services, Inc.	1994-06-10	196	0
K932143	FLEXI-TRAK ANCHORING DEVICE	Convatec, A Division of E.R. Squibb & Sons	1993-12-01	215	0
K931013	FOLEY CATHETER TRAY	Kit Pak, Inc.	1993-08-09	164	0
K926039	GUIDE-TECH ENCAPSULATED GUIDEWIRE	Cape Tech Medical Products	1993-08-05	247	0
K925161	NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO	North American Sterilization & Packaging Co.	1993-07-21	281	0
K923496	URINARY CARE SUPPLIES	Orion Life Systems, Inc.	1993-05-27	316	0
K925281	KIT PAK URINARY CARE SUPPLIES	Kit Pak, Inc.	1993-04-19	181	0
K926344	HYDROPHILIC COATED GUIDEWIRE	Surgitek	1993-03-05	78	0
K921200	GUIDEWIRE	Lake Region Mfg., Inc.	1992-09-04	176	0
K921055	KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER	Kendall Healthcare Products Co. Div.Of Tyco Health	1992-05-11	67	0
K912919	MENTOR INFUSION LINE	Mentor Corp.	1991-12-13	163	0
K914211	CATH CONTROL	Highpoint Medical Corp.	1991-11-22	64	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