Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiocom, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122285 | TABLET COMMANDER | Cardiocom, LLC | 2012-08-14 | 15 | 0 |
| K091821 | COMMANDER 111, MODEL CD300-CD399 | Cardiocom, LLC | 2009-08-25 | 68 | 0 |
| K053303 | CARDIOCOM COMMANDER III | Cardiocom, LLC | 2005-12-30 | 32 | 0 |
| K053304 | COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM | Cardiocom, LLC | 2005-12-30 | 32 | 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