Atlas FDA

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

Cytophil, Inc. — Predicate Candidate Screening

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

161 daysmedian FDA review time
248 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K150400Renu GelCytophil, Inc.2015-04-06470
K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTCytophil, Inc.2013-02-222480
K102937OSTEOPHIL BETA-TCPCytophil, Inc.2010-12-27840
K093871PERIOPHIL B-TCPCytophil, Inc.2010-04-221260
K092788PERIOPHIL BIPHASICCytophil, Inc.2009-12-18991
K081816VOCALIS AND VOCALIS SMCytophil, Inc.2009-01-051930
K081815VOCALIS GELCytophil, Inc.2009-01-051930
K072219CYTOPHIL TISSUE MARKERCytophil, Inc.2008-01-181610

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