Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KOB — Predicate Candidate Screening

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

71 daysmedian FDA review time

267 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days
K240514	AMT Low-Profile Suprapubic Catheter & Drainage Set	Applied Medical Technology, Inc.	2024-11-01	253
K181097	Cook Cystostomy Catheter Set	Cook Incorporated	2019-01-18	267
K182709	One-Step Suprapubic Introducer	Cook Incorporated	2018-12-26	90
K182066	O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer S	Cook Incorporated	2018-10-30	90
K132890	SUPRAPUBIC CATHETER AND INTRODUCER SET	Mediplus , Ltd.	2014-01-17	123
K120127	SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY	Swan Valley Medical, Incorporated	2012-10-26	283
K014002	ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890	Fortune Medical Instrument Corp.	2002-03-04	90
K012153	LOWSLEY SUPRAPUBIC TRACTOR	Circon Video	2001-09-19	70
K970969	KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT	The Kendal Co.	1997-04-23	37
K970021	RUSCH SUPRAPUBIC TRAY	Rusch, Inc.	1997-02-07	35
K945480	MOSS(R) STEEL BREAKAWAY(R) INTRODUCER	Harry A. Schlakman	1995-08-28	293
K953024	LINDNER/GOLOMB SP INTRODUCING SOUND	Cook Urological, Inc.	1995-08-18	50
K952187	RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE	Rusch, Inc.	1995-07-25	77
K921071	DENTOLOCK	Dentmed , Ltd.	1992-03-26	20
K904798	SUPRAPUBIC FLOW CONTROLLER	Olympus Corp.	1991-11-22	394
K904434	SEXTON CYSTOTOMY URINE PUMP (SCUP2)	Phoenix Bioengineering, Inc.	1991-02-01	126
K901938	SUPER STRENGTH DENTURE ADHESIVE CREAM	Teledyne Getz	1990-06-06	37
K901603	MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER	Bivona Medical Technologies	1990-05-04	38
K884061	ADD-A-CATH	Femcare , Ltd.	1988-10-25	29
K881097	SPEC 5* SUPRAPUBIC CATHETER	Porges Corp.	1988-06-03	80
K874530	URETHRAL DILATOR ENDOSCOPE	Advanced Surgical Intervention, Inc.	1988-01-27	85
K870556	VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET	Van-Tec, Inc.	1987-03-10	28
K870555	VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET	Van-Tec, Inc.	1987-03-10	28
K863386	VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS	Angiomed U.S., Inc.	1986-10-24	51
K863120	(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET	Cook Urological, Inc.	1986-10-24	71
K852287	PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET	Cook Ob/Gyn	1985-08-08	71
K852200	SIMPLASTIC SUPRA PUBIC CATHETER	Franklin Medical USA, Inc.	1985-08-07	78
K843158	SEXTON CYSTOTOMY URINE PUMP	Holter-Hausner Intl.	1984-10-04	55
K813084	CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET	Burron Medical Products, Inc.	1981-12-31	59
K810368	VANCE PERCUTANEOUS MALECOT NEPHROSTOMY	Vance Products, Inc.	1981-03-20	36
K800607	SUPRAPUBIC TROCAR	G.D. Searle and Co.	1980-04-08	22
K780765	PERCUTANEOUS SURAPUBIC CATHETER	Vance Products, Inc.	1978-07-17	73

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