Atlas FDA

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

Cardiocomm Solutions, Inc. — Predicate Candidate Screening

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

114 daysmedian FDA review time
531 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc.2019-02-222810
K122632GUAVA IICardiocomm Solutions, Inc.2014-02-115310
K121009HEARTCHECK ECG PEN WITH GEMS HOMECardiocomm Solutions, Inc.2012-05-17440
K111159HEARTCHECK PEN HANDHELD ECG WITH GEMS HOMECardiocomm Solutions, Inc.2011-12-222410
K111320GLOBALCARDIOCardiocomm Solutions, Inc.2011-10-071500
K033037MODIFICATION TO GLOBALCARDIOCardiocomm Solutions, Inc.2003-10-31320
K022297GLOBAL ECG MANAGEMENT SYSTEM (GEMS)Cardiocomm Solutions, Inc.2002-09-27730
K020366GLOBAL ECG MANAGEMENT SYSTEM (GEMS)Cardiocomm Solutions, Inc.2002-04-30850
K013354GLOBALCARDIOCardiocomm Solutions, Inc.2002-01-311140

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