Eaton Medical Group: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Eaton Medical Group” (first 1983, latest 1986), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 108 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 4 | 4 |
| DSF | Recorder, Paper Chart | 3 | 3 |
| IOL | Treadmill, Powered | 3 | 3 |
| DRW | Adaptor, Lead Switching, Electrocardiograph | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 2 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
Review panels
- Cardiovascular (12)
- Physical Medicine (3)
Most recent Eaton Medical Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851623 | MODEL TRC-40 TELEMETRY RECIEVER MODULE | DXH | 1986-01-22 | 279 |
| K851624 | MODEL TT-185 TELEMETRY TRANSMITTER | DXH | 1986-01-14 | 271 |
| K851625 | SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 | DSF | 1985-11-19 | 215 |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | DRW | 1985-11-08 | 204 |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | DRW | 1985-11-08 | 204 |
| K851631 | TMX-C1/C2 TRADMILL CONTROLLER ACCESS. | IOL | 1985-07-15 | 88 |
| K851630 | TMX-80 TREADMILL | IOL | 1985-07-09 | 82 |
| K851629 | TMX-70 TREADMILL | IOL | 1985-07-09 | 82 |
| K851628 | RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO | DXJ | 1985-06-27 | 70 |
| K851633 | CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL | DPS | 1985-06-26 | 69 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eaton Medical Group.
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.
- Eaton Medical Corp. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eaton Medical Group?
FDA lists 15 510(k) clearances under the applicant name “Eaton Medical Group” (first 1983, latest 1986), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eaton Medical Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eaton Medical Group is 108 days.
Which FDA product codes appear under Eaton Medical Group?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 4); DSF (Recorder, Paper Chart, 3); IOL (Treadmill, Powered, 3).
Next steps
- See all 15 Eaton Medical Group clearances with predicates and recalls
- Run predicate analysis for product code DPS, Eaton Medical Group'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.