Atlas FDA

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

Regulatory & Marketing Services, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
323 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBERegulatory & Marketing Services, Inc.1996-04-105660
K954752PEDIATRIC EUROPHYLIC FOLEY CATHETERRegulatory & Marketing Services, Inc.1995-10-30140
K941342PAIN DOCRegulatory & Marketing Services, Inc.1995-10-135980
K941543DIAL MEDICAL KITRegulatory & Marketing Services, Inc.1995-02-163230
K944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.1995-02-151610
K944378ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.1995-02-151610
K944384ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAGRegulatory & Marketing Services, Inc.1995-02-151610
K945874EUROMEDICAL POLY TRACHEOTOMY TUBERegulatory & Marketing Services, Inc.1994-12-27260
K944377ORION'S URINARY DRAINAGE SETRegulatory & Marketing Services, Inc.1994-12-06900
K944383ORION RED URETHRAL CATHETERRegulatory & Marketing Services, Inc.1994-12-06900
K944382ORION ALL SILICONE FOLEY CATHETERRegulatory & Marketing Services, Inc.1994-12-06900
K944381ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBERegulatory & Marketing Services, Inc.1994-11-30840
K944380ORION FOLEY CATHETERRegulatory & Marketing Services, Inc.1994-11-30840
K944376ORION ALL SILICONE ELASTOMER COATED CATHETERRegulatory & Marketing Services, Inc.1994-11-30840
K944230DIAL MEDICAL SUPPLY SHARPS CONTAINERRegulatory & Marketing Services, Inc.1994-11-07680
K935643SYRIGENE ACETIC ACID PRE-FILLEDSYRINGERegulatory & Marketing Services, Inc.1994-06-101960
K942274ORION SUCTION CATHETER KIT WITH STERILE SALINERegulatory & Marketing Services, Inc.1994-06-02230
K942273ORION SUCTION CATHETER KIT WITH STERILE WATERRegulatory & Marketing Services, Inc.1994-06-02230
K941542ORION CENTRAL LINE DRESSING CHANGE TRAYRegulatory & Marketing Services, Inc.1994-05-23540
K935669SYRIGENE PRE-FILLED SYRINGERegulatory & Marketing Services, Inc.1994-02-18840
K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.1993-07-222130

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