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

LJE — Predicate Candidate Screening

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

107 daysmedian FDA review time

257 days90th percentile

56clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250448	Disposable Percutaneous Nephrostomy Dilatation Kit	Shenzhen Trious Medical Technology Co., Ltd.	2025-07-03	135	0
K222705	Introducer Needle	Youcare Technology Co.,Ltd. (Wuhan)	2023-05-22	257	0
K211911	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutan	Coloplast Corp.	2022-03-10	262	0
K201165	In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz She	Coloplast Corp.	2020-12-17	230	0
K191498	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set w	Cook Incorporated	2020-01-29	238	0
K190903	Lawson Retrograde Nephrostomy Wire Puncture Set	Cook Incorporated	2019-12-16	252	0
K183051	Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set	Cook Incorporated	2019-07-16	256	0
K183035	Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Dis	Cook Incorporated	2019-05-17	197	0
K181735	Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nep	Cook Incorporated	2019-03-27	268	0
K181713	Ultraxx Nephrostomy Balloon Catheter Set	Cook Incorporated	2018-08-17	50	0
K171601	Ultraxx Nephrostomy Balloon Catheter	Cook Incorporated	2018-02-23	267	0
K172929	Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, a	Boston Scientific Corporation	2018-01-10	107	0
K172527	Amplatz Renal Dilator Set, Catheter for Use with Amplatz Ren	Cook Incorporated	2017-10-19	59	0
K160077	RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostom	Jbw7 Innovations, LLC	2016-07-12	180	0
K132383	GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CA	Gyrus Acmi, Inc.	2014-02-04	188	1
K121614	NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHET	Boston Scientific Corp	2012-09-18	109	3
K080944	X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER	C.R. Bard, Inc.	2008-10-23	203	0
K063632	X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER	C.R. Bard, Inc.	2007-01-05	30	0
K051316	X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER	C.R. Bard, Inc.	2005-07-18	59	0
K024050	COOK NEPHROSTOMY DILATION BALLOON CATHETER SET	Cook Urological, Inc.	2003-02-27	80	2
K011121	RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS	Rusch Intl.	2001-11-16	218	0
K990689	ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9	Zcv ,Inc.	1999-09-03	184	0
K981344	URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COAT	Uresil Corp.	1998-09-10	154	0
K980193	MANAN GENERAL UTILITY DRAINAGE CATHETER	Medical Device Technologies, Inc.	1998-05-27	127	0
K980192	MANAN NEPHROSTOMY DRAINAGE CATHETER	Medical Device Technologies, Inc.	1998-05-27	127	0
K980889	URESIL NEPHRO-URETERAL STENT	Uresil Corp.	1998-04-08	30	0
K961933	CIRCLE NEPHROSTOMY CATHETER SET	Cook Urological, Inc.	1996-07-18	62	0
K953713	MANAN GENERAL UTILITY DRAINAGE CATHETER	Manan Medical Products, Inc.	1996-03-26	251	0
K953601	MANAN UNIVERSAL SUMP DRAINAGE CATHETER	Manan Medical Products, Inc.	1996-03-26	237	0
K953547	MANAN NEPHROSTOMY DRAINAGE CATHETER	Manan Medical Products, Inc.	1995-08-30	33	0
K952887	NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER	Meadox Medicals, Div. Boston Scientific Corp.	1995-08-18	56	0
K952968	DILATATION CATHETER, BALLOON	Boston Scientific Corp	1995-08-10	44	0
K942688	NEPHRO-URETERAL STENT	Uresil Corp.	1995-06-06	364	0
K943893	PERCUTANEOUS GRAINAGE CATHETER	Menlo Care, Inc.	1995-03-07	210	0
K915209	MALECOT-NEPHROSTOMY TAMPONADE CATHETER	Cook Urological, Inc.	1992-11-10	358	0
K923097	URESIL NEPHROSTOMY CATHETER	Uresil Corp.	1992-09-14	81	0
K920509	URESIL SUMP DRAINAGE CATHETER	Uresil Corp.	1992-09-14	223	0
K891406	BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET	Cook Urological, Inc.	1989-04-07	24	0
K862742	NEPHROSTOMY SET	Meadox Surgimed, Inc.	1986-10-31	102	0
K850287	MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET	Mentor Corp.	1985-03-07	42	0
K850286	MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET	Mentor Corp.	1985-02-28	35	0
K845048	NEPHROSTOMY DRAINAGE CATHETER & STIFFENER	American Edwards Laboratories	1985-01-15	15	0
K845047	NEPHROSTOMY GUIDEWIRE SHEATH	American Edwards Laboratories	1985-01-15	15	0
K844090	PERCUTANEOUS NEPHROSTOMY TROCAR SYS	American Edwards Laboratories	1984-12-05	44	0
K842840	CURITY SILICONE NEPHROSTOMY CATHETER	The Kendal Co.	1984-10-04	76	0
K842121	E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE	E-Z-Em, Inc.	1984-10-01	125	0
K842899	CURITY SUPRAPUBIC DRAINAGE SYSTEM	The Kendal Co.	1984-09-10	49	0
K841720	E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS	E-Z-Em, Inc.	1984-07-26	92	0
K833762	PERCUTANEOUS RETROGRADE NEPHROSTOMY	Vpi	1984-02-10	107	0
K834476	NEPHROSTOMY/BILIARY DRAINAGE BAG	Vertex Medical Corp.	1984-02-04	46	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