General Devices: FDA clearances and approvals
General Devices has 13 FDA 510(k) clearances (first 1983, latest 2002), across 9 product codes in 2 review panels. Median 510(k) review time: 91 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 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
| GYA | Tester, Electrode/Lead, Electroencephalograph | 1 | 1 |
| GZO | Device, Galvanic Skin Response Measurement | 1 | 1 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | 1 | 1 |
Review panels
- Cardiovascular (11)
- Neurology (2)
Most recent General Devices 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013533 | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) | DRG | 2002-01-18 | 87 |
| K002089 | ROSETTA-LT/ROSETTA-RX | DRG | 2000-11-21 | 133 |
| K993202 | EIM-107 PREP-CHECK | GZO | 1999-12-17 | 84 |
| K940009 | GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 | DRG | 1995-04-14 | 465 |
| K935839 | GEMSCOM SERIES 5000, | DRG | 1994-11-10 | 338 |
| K921929 | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) | DXH | 1992-09-18 | 147 |
| K914889 | GEMSCOM SERIES 3000 | DRG | 1992-03-04 | 125 |
| K912008 | TRU-VIEW MULTI-CHANNEL DISPLAY | DRT | 1991-10-09 | 156 |
| K896153 | MODIFIED DR-2C/PMC 100 | DSH | 1990-01-19 | 87 |
| K862596 | DR-2C (MODIFICATION) | DSF | 1986-09-26 | 91 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named General Devices.
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 General Devices have?
General Devices has 13 FDA 510(k) clearances (first 1983, latest 2002), across 9 product codes in 2 review panels.
How long does FDA take to clear General Devices's 510(k)s?
The median time from FDA receipt to decision across General Devices's cleared 510(k)s is 91 days.
What devices does General Devices make?
Its most frequent FDA product codes are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 5); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1); DSF (Recorder, Paper Chart, 1).
Has General Devices had device recalls?
openFDA lists no recalls under a recalling firm name matching General Devices. Related entities may recall under other names.
Next steps
- See all 13 General Devices clearances with predicates and recalls
- Run predicate analysis for product code DRG, General Devices'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.