Atlas FDA

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

Mercury Medical — Predicate Candidate Screening

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

151 daysmedian FDA review time
372 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142096T-PIECE RESUSCITATORMercury Medical2014-10-17770
K090710MERCURY CPAPMercury Medical2009-08-201550
K083056NEO-STAT CO2 <KGMercury Medical2009-02-231320
K032593MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE Mercury Medical2004-02-031650
K031814STATCO2METER, MODEL 10-55372Mercury Medical2003-08-14630
K031411MINI STATCO2 CO2 DETECTOR, MODEL 10-55371Mercury Medical2003-07-30860
K021576MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-553Mercury Medical2002-11-041740
K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury Medical2000-11-031510
K000073MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULAMercury Medical2000-03-01511
K970756MERCURY MEDICAL REUSABLE CPR BAGMercury Medical1997-10-312420
K954492MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEXMercury Medical1996-10-213900
K954490MERCURY MEDICAL CPR BAG EXHALATION FILTERMercury Medical1996-10-033720
K954486MERCURY AIRWAY PRESSURE MANOMETERMercury Medical1996-04-252110
K954866MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDAMercury Medical1996-01-30980
K945901DIRECT VIEW 2001 FIBERLIGHTMercury Medical1994-12-27250

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