Atlas FDA

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

Argus Medical Co., Inc. — Predicate Candidate Screening

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

110 daysmedian FDA review time
213 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K950255ARGUS HYSTEROSCOPY INSTRUMENT SYSTEMArgus Medical Co., Inc.1995-08-242130
K951624ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSArgus Medical Co., Inc.1995-07-261100
K950242ARGUS ARTHROSCOPY INSTRUMENT SYSTEMArgus Medical Co., Inc.1995-05-151150
K950297ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEMArgus Medical Co., Inc.1995-03-03370
K946011ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEMArgus Medical Co., Inc.1995-02-17700
K950378ARGUS LAPAROSCOPY INSTRUMENT SYSTEMArgus Medical Co., Inc.1995-02-0990

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