Aerotel Medical Systems (1998) , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Aerotel Medical Systems (1998) , Ltd.” (first 1999, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
Review panels
- Cardiovascular (7)
Most recent Aerotel Medical Systems (1998) , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032736 | HEART 2006 | DXH | 2003-10-03 | 29 |
| K030825 | MPM-NET | DXN | 2003-03-28 | 14 |
| K023418 | HEARTONE EVENT RECORDER AND TRANSMITTER | DXH | 2002-11-06 | 26 |
| K022073 | HEARTLINE RECEIVING STATION | DXH | 2002-07-24 | 28 |
| K021447 | TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM | DXN | 2002-05-22 | 16 |
| K000775 | HEART 2005 | DXH | 2000-05-17 | 69 |
| K983717 | BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM | DXN | 1999-09-16 | 330 |
Recalls
openFDA lists no recalls under a recalling firm named Aerotel Medical Systems (1998) , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Aerotel, Ltd. (6 510(k)s)
- Aerotel Medical Systems, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aerotel Medical Systems (1998) , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Aerotel Medical Systems (1998) , Ltd.” (first 1999, latest 2003), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aerotel Medical Systems (1998) , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aerotel Medical Systems (1998) , Ltd. is 28 days.
Which FDA product codes appear under Aerotel Medical Systems (1998) , Ltd.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3).
Next steps
- See all 7 Aerotel Medical Systems (1998) , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Aerotel Medical Systems (1998) , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.