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

Medtronic Xomed · Predicate Candidate Screening

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

84 daysmedian FDA review time

226 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K202623	Novapak Nasal Sinus Packing and Stent	Medtronic Xomed	2020-12-08	89	0
K122434	MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS ST	Medtronic Xomed	2012-10-31	82	0
K031510	NIM-SPINE	Medtronic Xomed	2003-06-18	35	0
K002972	MEROGEL CONTROL GEL ENT SURGICAL DRESSING	Medtronic Xomed	2000-12-15	84	0
K002224	XPS 3000 SYSTEM	Medtronic Xomed	2000-12-04	133	0
K000728	MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE	Medtronic Xomed	2000-03-21	15	0
K990793	ACCUGUIDE MUSCLE INJECTION MONITOR	Medtronic Xomed	1999-10-22	226	1
K963727	HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER	Medtronic Xomed	1997-02-11	148	0
K963246	TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT	Medtronic Xomed	1996-09-23	35	0

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