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

Anthogyr Sas — Predicate Candidate Screening

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

246 daysmedian FDA review time

415 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K161177	Axiom PX	Anthogyr Sas	2017-06-15	415	0
K141450	AXIOM 2.8	Anthogyr Sas	2014-09-17	107	1
K131066	AXIOM REG	Anthogyr Sas	2014-02-21	311	0
K111532	MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE	Anthogyr Sas	2011-10-07	126	0
K102241	ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UN	Anthogyr Sas	2011-03-23	226	0
K101913	ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM	Anthogyr Sas	2011-03-11	246	1

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