Aerotel, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Aerotel, Ltd.” (first 1994, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 318 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 | 5 | 5 |
| DPS | Electrocardiograph | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Aerotel, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980144 | HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER | DXH | 1998-06-16 | 152 |
| K953762 | HEART 400 ECG TRANSMITTER | DXH | 1996-07-18 | 342 |
| K961362 | AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE | DXH | 1996-07-10 | 92 |
| K950004 | HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER | DPS | 1995-10-24 | 294 |
| K931020 | HEART 1001 | DXH | 1995-01-11 | 684 |
| K930314 | HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE | DXH | 1994-03-18 | 420 |
Recalls
openFDA lists no recalls under a recalling firm named Aerotel, 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 Medical Systems (1998) , Ltd. (7 510(k)s)
- Aerotel Medical Systems, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aerotel, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Aerotel, Ltd.” (first 1994, latest 1998), 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, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aerotel, Ltd. is 318 days.
Which FDA product codes appear under Aerotel, Ltd.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 5); DPS (Electrocardiograph, 1).
Next steps
- See all 6 Aerotel, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Aerotel, 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.