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

Rusch, Inc. — Predicate Candidate Screening

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

183 daysmedian FDA review time
529 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K010420RUSCH MMG/O'NEIL CATHETERRusch, Inc.2001-05-09862
K993528RUSCH EMERGENCY MASKRusch, Inc.2000-05-312260
K993194RUSCH MANUAL RESUSCITATOR BAGRusch, Inc.2000-03-241830
K980870RUSCH SILICONE FOLEY CATHETERRusch, Inc.1998-06-09970
K974419RUSCH SIMPLASTIC COUNCILL TIP CATHETERRusch, Inc.1998-01-27640
K963779RUSCH ENTERAL FEEDING TUBERusch, Inc.1997-05-232450
K970021RUSCH SUPRAPUBIC TRAYRusch, Inc.1997-02-07350
K963993RUSCH SIMPLASTIC FOLEY CATHETERIZATION SETRusch, Inc.1996-12-17740
K955564RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILERusch, Inc.1996-06-282050
K955495RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILERusch, Inc.1996-06-272090
K953963RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & Rusch, Inc.1995-11-27970
K922567LOW PROFILE CATHETERRusch, Inc.1995-11-2112680
K953593RUSCH TRACHEAL BRONCHIAL Y STENTRusch, Inc.1995-10-13740
K952100RUSCH ENDOTRACHEAL TUBE STYLETRusch, Inc.1995-08-08960
K952187RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILERusch, Inc.1995-07-25770
K935842RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYRusch, Inc.1995-05-235321
K922998ENFUSE ENTERAL FEEDING TUBERusch, Inc.1993-12-035290
K925505RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYERusch, Inc.1993-09-023070
K925508RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIPRusch, Inc.1993-09-022970
K925507RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIPRusch, Inc.1993-09-023070
K925506RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYERusch, Inc.1993-08-022760
K931163RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYERusch, Inc.1993-06-2310712
K931164RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EYRusch, Inc.1993-06-2310710
K931165RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYERusch, Inc.1993-06-221067
K931166RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EYRusch, Inc.1993-06-221069
K923003PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.Rusch, Inc.1993-04-152970

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