American Telecare, Inc.: FDA clearances and approvals
American Telecare, Inc. has 9 FDA 510(k) clearances (first 1995, latest 2003), across 4 product codes in 1 review panel. Median 510(k) review time: 164 days.
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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 5 | 5 |
| DQD | Stethoscope, Electronic | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent American Telecare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030222 | NX SYSTEM | DRG | 2003-08-19 | 209 |
| K003999 | AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 | MWI | 2001-06-28 | 184 |
| K993550 | AVIVA SYSTEM, MODEL SL1010 | DRG | 2000-01-13 | 85 |
| K981533 | AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 | DRG | 1998-07-15 | 77 |
| K973873 | DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 | DRG | 1997-12-29 | 80 |
| K963678 | CARETONE II | DQD | 1997-02-24 | 164 |
| K964554 | PERSONAL TELEMEDICINE MODULE | DRG | 1996-12-17 | 34 |
| K952882 | PERSONAL TELEMEDICINE SYSTEM | DXN | 1996-09-09 | 444 |
| K945638 | TELPHONIC STETHOSCOPE | DQD | 1995-05-17 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named American Telecare, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does American Telecare, Inc. have?
American Telecare, Inc. has 9 FDA 510(k) clearances (first 1995, latest 2003), across 4 product codes in 1 review panel.
How long does FDA take to clear American Telecare, Inc.'s 510(k)s?
The median time from FDA receipt to decision across American Telecare, Inc.'s cleared 510(k)s is 164 days.
What devices does American Telecare, Inc. make?
Its most frequent FDA product codes are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 5); DQD (Stethoscope, Electronic, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Has American Telecare, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Telecare, Inc. Related entities may recall under other names.
Next steps
- See all 9 American Telecare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRG, American Telecare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.