Atlas FDA

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

Rochester Medical Corp. — Predicate Candidate Screening

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

117 daysmedian FDA review time
256 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122785HYDROSIL; MAGIC; PERSONAL CATHETERRochester Medical Corp.2013-05-142453
K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENRochester Medical Corp.2004-06-102201
K001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSORochester Medical Corp.2000-07-07880
K000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HRochester Medical Corp.2000-05-197423
K981612ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WRochester Medical Corp.1998-07-08630
K971627SILICONE ANTIBACTERIAL FOLEY CATHETERRochester Medical Corp.1998-01-132560
K970704PERSONAL CATHETERRochester Medical Corp.1997-03-13150
K952082ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETERochester Medical Corp.1995-07-18760
K941692FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETERRochester Medical Corp.1995-03-063340
K943851ALL SILICONE INTERMITTENT CATHETERRochester Medical Corp.1995-01-311760
K923136MALE EXTERNAL CATHETERRochester Medical Corp.1992-12-031570
K905042COMFORT SLEEVED ALL SILICONE FOLEY CATHETERRochester Medical Corp.1991-01-18720
K896053ALL SILICONE FOLEY CATHETERRochester Medical Corp.1990-02-121170

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