Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Puritas Health Care, Inc. · Predicate Candidate Screening

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

100 daysmedian FDA review time
170 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942339SKIN NEUVEAU SCAR TREATMENTPuritas Health Care, Inc.1994-11-281960
K941197SILK*SKIN SCAR TREATMENTPuritas Health Care, Inc.1994-08-111500
K935600TRACHEAL SUCTION CATHETERPuritas Health Care, Inc.1994-05-101720
K935531OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIPPuritas Health Care, Inc.1994-05-051700
K940074Y-TYPE BLOOD ADMINISTRATION SETPuritas Health Care, Inc.1994-04-211050
K940054MEASURED VOLUME SOLUTION ADMINISTRATION SETPuritas Health Care, Inc.1994-04-151000
K940055MULTISETPuritas Health Care, Inc.1994-04-151000
K935583SUCTION SET, TRACHAELPuritas Health Care, Inc.1994-04-111440
K935532TRANSFER SETPuritas Health Care, Inc.1994-04-041390
K940056WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEMPuritas Health Care, Inc.1994-04-04890
K940070STOPCOCK INTRAVENOUS THERAPYPuritas Health Care, Inc.1994-04-04880
K940053INFUSION ADMINISTRATION SETPuritas Health Care, Inc.1994-03-28820
K9402931.2 MICRON FINAL FILTER WITH EXTENSION TUBEPuritas Health Care, Inc.1994-03-28660
K940072I.V. SET (20 DROPS/ML)Puritas Health Care, Inc.1994-03-23760
K940073EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30Puritas Health Care, Inc.1994-03-23760
K935557URINARY DRAINAGE BAGPuritas Health Care, Inc.1994-03-071100
K935533NASAL CANNULAPuritas Health Care, Inc.1994-02-03790
K9356010.22 MICRON FINAL FILTER WITH EXTENSION TUBEPuritas Health Care, Inc.1994-01-21630
K935553MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTPuritas Health Care, Inc.1994-01-14580
K935582TUBE, INHALER OXYGENPuritas Health Care, Inc.1994-01-14570
K935578URINE METERPuritas Health Care, Inc.1993-12-17290
K920501SILCLAMPS DEGANIA SILICONEPuritas Health Care, Inc.1992-06-021190
K920104IDENTI LOOPS DEGANIA SILICONEPuritas Health Care, Inc.1992-04-201020
K912542PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELSPuritas Health Care, Inc.1991-07-23430

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