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

Xylos Corporation — Predicate Candidate Screening

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

86 daysmedian FDA review time

221 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K111584	XYLOS MACRO-POROUS SURGICAL MESH	Xylos Corporation	2011-08-25	79
K100984	XYLOS VESSEL GUARD	Xylos Corporation	2010-07-07	90
K090880	XYLOS POROUS SURGICAL MESH	Xylos Corporation	2009-05-27	57
K090778	MTA PROTECTIVE SHEET	Xylos Corporation	2009-04-28	36
K083823	SECURIAN TISSUE REINFORCEMENT MATRIX	Xylos Corporation	2009-03-18	86
K081882	MODIFICATION TO XYLOS SURGICAL MESH	Xylos Corporation	2008-07-11	9
K023237	XYLOS SURGICAL MESH	Xylos Corporation	2003-03-18	172
K024054	XYLOS XCELL ANTIMICROBIAL DRESSING	Xylos Corporation	2003-03-07	88
K974251	X-CELL WOUND DRESSING	Xylos Corporation	1998-06-22	221

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