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

V. Mueller Neuro/Spine — Predicate Candidate Screening

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

204 daysmedian FDA review time

351 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K002276	PSI SKULL CLAMP	V. Mueller Neuro/Spine	2000-08-29	34
K993019	PACIFIC SURGICAL PATTIES	V. Mueller Neuro/Spine	2000-03-30	204
K991959	PSI TITANIUM ANEURYSM CLIP	V. Mueller Neuro/Spine	2000-01-06	210
K991002	PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP	V. Mueller Neuro/Spine	1999-06-11	78
K972750	TAKA ANEURYSM CLIP	V. Mueller Neuro/Spine	1998-07-09	351
K964402	VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM	V. Mueller Neuro/Spine	1997-01-23	80
K942601	PSI FLEXIBLE ARM	V. Mueller Neuro/Spine	1994-12-27	209
K943635	ULTRA-LINE RONGEUR	V. Mueller Neuro/Spine	1994-12-07	133

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