Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paieon, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
444 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120282 | CARDNAV | Paieon, Inc. | 2012-12-10 | 314 | 0 |
| K113594 | C-THV SYSTEM | Paieon, Inc. | 2012-03-02 | 88 | 0 |
| K110256 | THE IC-PRO SYSTEM | Paieon, Inc. | 2011-05-27 | 119 | 0 |
| K083745 | THE IC-PRO SYSTEM, MODEL VERSION 3.2 | Paieon, Inc. | 2009-02-17 | 63 | 0 |
| K082907 | IC-PRO SYSTEM, VERSION 3.1.0.4 | Paieon, Inc. | 2008-11-18 | 49 | 0 |
| K073328 | CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA | Paieon, Inc. | 2008-09-09 | 287 | 0 |
| K072591 | CARDIOP-B SYSTEM, VERSION 2.1 | Paieon, Inc. | 2007-10-10 | 26 | 0 |
| K030139 | THE CARDIOP-B SYSTEM | Paieon, Inc. | 2004-04-02 | 444 | 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