Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aerotel, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
342 daysmedian FDA review time
684 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980144 | HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER | Aerotel, Ltd. | 1998-06-16 | 152 | 0 |
| K953762 | HEART 400 ECG TRANSMITTER | Aerotel, Ltd. | 1996-07-18 | 342 | 0 |
| K961362 | AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE | Aerotel, Ltd. | 1996-07-10 | 92 | 0 |
| K950004 | HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTE | Aerotel, Ltd. | 1995-10-24 | 294 | 0 |
| K931020 | HEART 1001 | Aerotel, Ltd. | 1995-01-11 | 684 | 0 |
| K930314 | HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE | Aerotel, Ltd. | 1994-03-18 | 420 | 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