Compumed, Inc.: FDA clearances and approvals
Compumed, Inc. has 6 FDA 510(k) clearances (first 1977, latest 1999), across 6 product codes in 3 review panels. Median 510(k) review time: 76 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| KGI | Densitometer, Bone | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Cardiovascular (3)
- Radiology (2)
- Anesthesiology (1)
Most recent Compumed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984285 | OSTEOGRAM BONE DENSITOMETER | KGI | 1999-05-19 | 169 |
| K955708 | COMPUMED DICON CLIENT | LMD | 1996-03-01 | 78 |
| K863965 | KENZ-ECG 102 | DXK | 1986-12-22 | 73 |
| K854626 | COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B | BZC | 1986-02-28 | 102 |
| K802272 | COMPUTER ECG TERMINAL | DSI | 1980-09-26 | 9 |
| K771648 | COMPUTER ECG TERMINAL | DXH | 1977-09-20 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Compumed, 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 Compumed, Inc. have?
Compumed, Inc. has 6 FDA 510(k) clearances (first 1977, latest 1999), across 6 product codes in 3 review panels.
How long does FDA take to clear Compumed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Compumed, Inc.'s cleared 510(k)s is 76 days.
What devices does Compumed, Inc. make?
Its most frequent FDA product codes are BZC (Calculator, Pulmonary Function Data, 1); DSI (Detector And Alarm, Arrhythmia, 1); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Has Compumed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Compumed, Inc. Related entities may recall under other names.
Next steps
- See all 6 Compumed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZC, Compumed, 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.