Atlas FDA

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

Onux Medical, Inc. · Predicate Candidate Screening

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

80 daysmedian FDA review time
90 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023372NON-BIOABSORBABLE STAPLEOnux Medical, Inc.2002-12-27800
K022777MANUAL TOUCHE SYSTEMOnux Medical, Inc.2002-11-19900
K014286SALUTE, MODEL 3022Onux Medical, Inc.2002-03-08710
K010620ENDOSCOPIC STAPLE REMOVAL INSTRUMENTOnux Medical, Inc.2001-05-17770
K003522SALUTEOnux Medical, Inc.2001-02-13900

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