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

Aspide Medical — Predicate Candidate Screening

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

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120025	SURGIMESH XB - SKIRTED	Aspide Medical	2012-06-26	175	0
K092233	SURGIMESH XD	Aspide Medical	2010-06-25	337	0
K072974	SURGIMESH XB	Aspide Medical	2008-08-18	301	2
K061445	SURGIMESH WN	Aspide Medical	2007-02-01	253	2

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