Devcom, Inc.: FDA clearances and approvals
Devcom, Inc. has 6 FDA 510(k) clearances (first 1985, latest 1990), across 6 product codes in 4 review panels. Median 510(k) review time: 15 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| IKK | System, Isokinetic Testing And Evaluation | 1 | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (2)
- Orthopedic (1)
- Physical Medicine (1)
- Radiology (1)
Most recent Devcom, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902378 | CARDIOTHORACIC RULER | KPR | 1990-06-14 | 16 |
| K874233 | BLOOD PRESSURE SLEEVE W/TUBING | DXQ | 1988-03-22 | 159 |
| K863313 | GRIP STRENGTH DEVICE (GSD) | IKK | 1986-09-09 | 14 |
| K861264 | JOINT MEASUREMENT INDICATOR | JDL | 1986-04-15 | 11 |
| K861043 | SPINAL EXCURSION METER | — | 1986-03-28 | 10 |
| K850021 | ELECTROCARDIOGRAPH-ECG CALIPER | DPS | 1985-02-08 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Devcom, 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 Devcom, Inc. have?
Devcom, Inc. has 6 FDA 510(k) clearances (first 1985, latest 1990), across 6 product codes in 4 review panels.
How long does FDA take to clear Devcom, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Devcom, Inc.'s cleared 510(k)s is 15 days.
What devices does Devcom, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 1); DXQ (Blood Pressure Cuff, 1); IKK (System, Isokinetic Testing And Evaluation, 1).
Has Devcom, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Devcom, Inc. Related entities may recall under other names.
Next steps
- See all 6 Devcom, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Devcom, 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.