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

Storz — Predicate Candidate Screening

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

253 daysmedian FDA review time

384 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960007	STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	Storz	1996-03-26	84	0
K952151	STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201,	Storz	1996-03-04	301	0
K954340	STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE	Storz	1995-12-14	87	5
K930278	STORZ COMPUSCAN AB	Storz	1994-02-09	384	0
K926512	STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE	Storz	1993-09-09	253	0
K913504	STORZ MICRO CUTTER 25 GAUGE PACK	Storz	1992-02-21	198	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