Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Aerotel Medical Systems (1998) , Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
330 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032736 | HEART 2006 | Aerotel Medical Systems (1998) , Ltd. | 2003-10-03 | 29 | 0 |
| K030825 | MPM-NET | Aerotel Medical Systems (1998) , Ltd. | 2003-03-28 | 14 | 0 |
| K023418 | HEARTONE EVENT RECORDER AND TRANSMITTER | Aerotel Medical Systems (1998) , Ltd. | 2002-11-06 | 26 | 0 |
| K022073 | HEARTLINE RECEIVING STATION | Aerotel Medical Systems (1998) , Ltd. | 2002-07-24 | 28 | 0 |
| K021447 | TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREM | Aerotel Medical Systems (1998) , Ltd. | 2002-05-22 | 16 | 0 |
| K000775 | HEART 2005 | Aerotel Medical Systems (1998) , Ltd. | 2000-05-17 | 69 | 0 |
| K983717 | BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM | Aerotel Medical Systems (1998) , Ltd. | 1999-09-16 | 330 | 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