Atlas FDA

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

Quali-Med, Inc. — Predicate Candidate Screening

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

46 daysmedian FDA review time
74 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K871408BLOOD VESSEL CONNECTORQuali-Med, Inc.1987-04-27190
K862972DISPOSABLE MIRRORQuali-Med, Inc.1986-09-23480
K862472QUARTZ RODS TITANIUM RODSQuali-Med, Inc.1986-09-12740
K862241STANDARD BASIN KIT CUSTOM BASIN KITQuali-Med, Inc.1986-08-01500
K862242PAP SMEAR KITQuali-Med, Inc.1986-06-26140
K862172QUALI-MED'S OPERATING ROOM DRAPESQuali-Med, Inc.1986-06-19100
K861198CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)Quali-Med, Inc.1986-05-16460

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