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

Rusch Intl. — Predicate Candidate Screening

43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

95 daysmedian FDA review time

280 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K033023	INTERMITTENT URETHRAL CATHETERS	Rusch Intl.	2003-12-23	88	0
K030559	RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY	Rusch Intl.	2003-06-30	129	0
K023666	RUSCH GUIDED CHOLANGIOGRAPHY CATHETER	Rusch Intl.	2003-06-17	229	0
K023918	RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS	Rusch Intl.	2003-03-28	123	2
K023964	RUSCH MICROLARYNGEAL TUBE	Rusch Intl.	2002-12-23	24	0
K021540	RUSCH EDGAR TUBE	Rusch Intl.	2002-08-01	83	0
K021764	RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED	Rusch Intl.	2002-07-23	55	0
K020714	RUSCH FLONEIL; FLOCATH INTROGEL	Rusch Intl.	2002-07-01	118	0
K010797	RUSCH MILLER-ABBOTT TUBE	Rusch Intl.	2002-02-26	347	0
K010798	RUSCH CANTOR TUBE	Rusch Intl.	2002-02-26	347	0
K013872	RUSCH MEMORY BAG	Rusch Intl.	2002-02-12	83	0
K013266	RUSCH POLYFLEX STENT KIT	Rusch Intl.	2001-11-27	57	0
K010596	RUSCH BRONCHUS BLOCKER KIT	Rusch Intl.	2001-11-21	266	0
K011121	RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS	Rusch Intl.	2001-11-16	218	0
K011122	BALLPEN SPINAL NEEDLE W/WO INTRODUCER	Rusch Intl.	2001-11-16	218	0
K011210	THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY	Rusch Intl.	2001-08-15	118	0
K010068	RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTE	Rusch Intl.	2001-02-08	31	9
K000070	FLOCATH	Rusch Intl.	2000-02-18	39	1
K993786	RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, M	Rusch Intl.	2000-02-02	86	3
K993063	RUSCH BRILLANT SILICONE FOLEY	Rusch Intl.	1999-12-09	87	0
K990619	RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND	Rusch Intl.	1999-08-03	159	1
K982974	DD URETERAL STENT, INTEGRAL STENT	Rusch Intl.	1999-07-02	311	0
K983010	SELF CATH SET/SAFETY CATH	Rusch Intl.	1999-02-12	168	0
K982614	RUSCH POLYFLEX STENT KIT	Rusch Intl.	1998-12-04	130	0
K983125	EPIDURAL CATHETER MODELS 1210/1200	Rusch Intl.	1998-11-17	70	0
K981203	RUSCH BLAKEMORE 3 LUMEN, STERILE	Rusch Intl.	1998-06-05	64	1
K973892	RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)	Rusch Intl.	1998-05-18	216	0
K972546	RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET	Rusch Intl.	1998-04-14	280	0
K972423	RUSCH TRACHEOFIX-SET	Rusch Intl.	1998-02-13	231	0
K972184	RUSCH BRILLANT SILICONE FOLEY CATHETER	Rusch Intl.	1998-01-08	212	0
K964056	RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUS	Rusch Intl.	1997-10-10	366	1
K971643	RUSCH BRILLANT BALLOON CATHETER	Rusch Intl.	1997-10-07	155	0
K964575	SYMPACATH HYDROGEL COATED FOLEY	Rusch Intl.	1997-02-04	82	0
K962472	RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER	Rusch Intl.	1996-08-27	63	1
K961837	RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY	Rusch Intl.	1996-08-16	95	33
K961840	RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY	Rusch Intl.	1996-06-27	45	24
K954585	RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE -	Rusch Intl.	1996-05-10	221	0
K960240	RUSCH OPTOSAFE	Rusch Intl.	1996-04-19	94	0
K955238	RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE	Rusch Intl.	1996-02-06	84	0
K952573	RUSCH URODYNAMIC RECTAL BALLOON CATHETER	Rusch Intl.	1995-06-15	10	0
K952029	RUSCH INTERNATIONAL URODYNAMIC CATHETERS	Rusch Intl.	1995-06-13	43	0
K951091	RUSCH ENDOBRONCHIAL TUBE SETS	Rusch Intl.	1995-06-08	91	10
K951046	RUSCH ENDOTEST CUFF PRESSURE MONITOR	Rusch Intl.	1995-04-06	31	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