Bio-Med Devices, Inc.: FDA clearances and approvals
Bio-Med Devices, Inc. has 14 FDA 510(k) clearances (first 1980, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time: 76 days. openFDA lists 9 product recalls by a recalling firm named Bio-Med Devices, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 203 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bio-Med Devices, Inc.'s cleared 510(k)s took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 240 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 9 | 9 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 2 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 | 1 |
Review panels
- Anesthesiology (14)
Most recent Bio-Med Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213948 | OxyMinder | CCL | 2022-03-17 | 90 |
| K173973 | TV-100 | CBK | 2018-07-20 | 203 |
| K942938 | CROSSVENT-4 VENTILATOR | CBK | 1995-09-19 | 454 |
| K896381 | MVP-10 MRI INFANT VENTILATOR | CBK | 1990-02-12 | 98 |
| K896380 | IC-2A MRI ADULT/PEDIATRIC VENTILATOR | CBK | 1990-02-12 | 98 |
| K873614 | CBG CUFF MANOMETER | BSK | 1988-01-22 | 136 |
| K871337 | M-2 OXYGEN/TEMPERATURE MONITOR | CCL | 1987-06-05 | 63 |
| K871336 | M-1 PRESSURE MONITOR | CAP | 1987-06-05 | 63 |
| K871139 | M-10 VENTILATION MONITOR | CAP | 1987-04-21 | 29 |
| K830230 | PROGRAMMABLE VENTILATOR | CBK | 1983-02-09 | 12 |
4 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2004-12-06.
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 Bio-Med Devices, Inc. have?
Bio-Med Devices, Inc. has 14 FDA 510(k) clearances (first 1980, latest 2022), across 4 product codes in 1 review panel.
How long does FDA take to clear Bio-Med Devices, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bio-Med Devices, Inc.'s cleared 510(k)s is 76 days.
What devices does Bio-Med Devices, Inc. make?
Its most frequent FDA product codes are CBK (Ventilator, Continuous, Facility Use, 9); CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 2); CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 2).
Has Bio-Med Devices, Inc. had device recalls?
openFDA lists 9 product recalls in 2 recall events by a recalling firm whose name matches Bio-Med Devices, Inc; the most recent began 2004-12-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 14 Bio-Med Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Bio-Med Devices, 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.