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

Innovaquartz — Predicate Candidate Screening

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

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050108	SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS	Innovaquartz	2005-03-14	55	6
K994010	INNOVAQUARTZ GENERAL SHAPE LASER FIBER	Innovaquartz	1999-12-17	21	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