Berkeley Medevices: FDA clearances and approvals
Berkeley Medevices has 5 FDA 510(k) clearances (first 1981, latest 1989), across 5 product codes in 2 review panels. Median 510(k) review time: 72 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 |
|---|---|---|---|
| GAD | Retractor | 1 | 1 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 | 1 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | 1 | 1 |
| HHI | System, Abortion, Vacuum | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
Review panels
Most recent Berkeley Medevices 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892220 | LAMINARIA TENT | HDY | 1989-06-14 | 72 |
| K840952 | MEDEVICE V-80 VACUUM PUMP | HHI | 1984-03-30 | 25 |
| K823006 | MEDEVICES ASPIRATION HOSE | HHK | 1982-11-04 | 23 |
| K812389 | SURGICAL LOOPS | GAD | 1981-11-16 | 88 |
| K812388 | SURGICAL PAWS | GDJ | 1981-11-16 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Berkeley Medevices.
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 Berkeley Medevices have?
Berkeley Medevices has 5 FDA 510(k) clearances (first 1981, latest 1989), across 5 product codes in 2 review panels.
How long does FDA take to clear Berkeley Medevices's 510(k)s?
The median time from FDA receipt to decision across Berkeley Medevices's cleared 510(k)s is 72 days.
What devices does Berkeley Medevices make?
Its most frequent FDA product codes are GAD (Retractor, 1); GDJ (Clamp, Surgical, General & Plastic Surgery, 1); HDY (Dilator, Cervical, Hygroscopic-Laminaria, 1).
Has Berkeley Medevices had device recalls?
openFDA lists no recalls under a recalling firm name matching Berkeley Medevices. Related entities may recall under other names.
Next steps
- See all 5 Berkeley Medevices clearances with predicates and recalls
- Run predicate analysis for product code GAD, Berkeley Medevices'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.