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

Cosman Medical, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time

139 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K101131	FIDUCIAL MARKERS	Cosman Medical, Inc.	2010-06-17	56	0
K082051	COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4	Cosman Medical, Inc.	2008-10-16	90	0
K082012	COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP	Cosman Medical, Inc.	2008-10-14	91	0
K060799	COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA	Cosman Medical, Inc.	2006-05-02	39	0
K053415	LESIONPOINT RF CANNULA	Cosman Medical, Inc.	2006-04-25	139	0
K050084	COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMI	Cosman Medical, Inc.	2005-03-17	63	2

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