Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paceart, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
259 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012407 | PACEART TX3 CARDIAC EVENT RECORDER | Paceart, Inc. | 2001-08-14 | 15 | 0 |
| K982090 | PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM | Paceart, Inc. | 1999-01-26 | 225 | 0 |
| K973141 | HEART ACCESS PLUS CARDIAC EVENT RECORDER | Paceart, Inc. | 1997-11-12 | 83 | 0 |
| K960721 | PACEART WRIST ELECTRODES | Paceart, Inc. | 1996-07-18 | 147 | 0 |
| K952065 | PACEART CARDIOVOICE | Paceart, Inc. | 1996-01-16 | 259 | 0 |
| K931296 | PACEART CARDIOPHONE | Paceart, Inc. | 1993-10-01 | 185 | 0 |
| K915632 | PACEART CPTS-86/12 | Paceart, Inc. | 1992-04-14 | 119 | 0 |
| K880283 | PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS | Paceart, Inc. | 1988-03-09 | 47 | 0 |
| K870909 | PACEMAKER FUNCTION ANALYZER | Paceart, Inc. | 1987-04-27 | 53 | 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