Atlas FDA

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

Marquette Medical, Inc. — Predicate Candidate Screening

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

121 daysmedian FDA review time
251 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021471MARQUETTE HUBER TRAP SAFETY INFUSION SETMarquette Medical, Inc.2003-09-084880
K953008INFANT FEEDING TUBEMarquette Medical, Inc.1996-01-111970
K952976PLASTIC BLUNT CANNULAMarquette Medical, Inc.1995-09-15800
K920537SUBCUTANEOUS INFUSION SETMarquette Medical, Inc.1992-10-132510
K9052194' LOW VOLUME IV EXTENSION SETMarquette Medical, Inc.1991-06-041960
K9052184 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMPMarquette Medical, Inc.1991-06-041960
K905374IV EXTENSION SETS WITH .22 MICRON FILTERMarquette Medical, Inc.1991-05-311830
K901088LOW VOLUME BIFURCATED IV EXTENSION SETMarquette Medical, Inc.1990-10-042110
K901089LOW VOLUME TRIFURCATED IV EXTENSION SETMarquette Medical, Inc.1990-10-042110
K900427IV TRIFURCATED EXTENSION SETMarquette Medical, Inc.1990-02-28290
K900426IV BIFURCATED EXTENSION SETMarquette Medical, Inc.1990-02-28290
K884211STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLESMarquette Medical, Inc.1988-10-17110
K884212WINGED NON-CORING NEEDLE SETMarquette Medical, Inc.1988-10-17110
K880928MARQUETTE MEDICAL, INC. IV EXTENSION SETSMarquette Medical, Inc.1988-04-29560
K875186IV EXTENSION SETMarquette Medical, Inc.1988-02-16560
K873495PUMP TUBING SETMarquette Medical, Inc.1987-12-301210
K873494RESERVOIR BAGMarquette Medical, Inc.1987-12-301210

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