Atlas FDA

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

Kerberos Proximal Solutions, Inc. — Predicate Candidate Screening

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

80 daysmedian FDA review time
118 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K062275RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, PKerberos Proximal Solutions, Inc.2006-09-20440
K050130KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEMKerberos Proximal Solutions, Inc.2005-05-131120
K041123RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FGKerberos Proximal Solutions, Inc.2004-08-261180
K041151KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIESKerberos Proximal Solutions, Inc.2004-07-22800
K041291RINSPIRATION SYSTEMKerberos Proximal Solutions, Inc.2004-05-2170

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