Vidco, Inc.: FDA clearances and approvals
Vidco, Inc. has 7 FDA 510(k) clearances (first 1989, latest 1997), across 3 product codes in 1 review panel. Median 510(k) review time: 360 days. openFDA lists 1 product recall by a recalling firm named Vidco, Inc.
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 |
|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | 5 | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Vidco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972880 | MDP2000 MEDICAL DATA PROCESSOR | MSX | 1997-10-22 | 78 |
| K934093 | 580CDR DISPLAY DRIVER | DXJ | 1994-08-18 | 360 |
| K932894 | 620CSR DISPLAY DRIVER | DXJ | 1994-06-20 | 371 |
| K926298 | 520 DISPLAY DRIVER- STATUS I | DRT | 1994-05-04 | 506 |
| K926219 | 516YT DISPLAY DRIVER | DXJ | 1993-12-16 | 371 |
| K926162 | 580CD DISPLAY DRIVER | DXJ | 1993-11-08 | 335 |
| K890353 | SMDS460 SURGICAL MONITOR DISPLAY SYSTEM | DXJ | 1989-03-02 | 37 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-11-08.
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 Vidco, Inc. have?
Vidco, Inc. has 7 FDA 510(k) clearances (first 1989, latest 1997), across 3 product codes in 1 review panel.
How long does FDA take to clear Vidco, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vidco, Inc.'s cleared 510(k)s is 360 days.
What devices does Vidco, Inc. make?
Its most frequent FDA product codes are DXJ (Display, Cathode-Ray Tube, Medical, 5); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1); MSX (System, Network And Communication, Physiological Monitors, 1).
Has Vidco, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Vidco, Inc; the most recent began 2015-11-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Vidco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXJ, Vidco, 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.