Beacon Laboratories, Inc.: FDA clearances and approvals
Beacon Laboratories, Inc. has 18 FDA 510(k) clearances (first 1989, latest 1994), across 4 product codes in 2 review panels. Median 510(k) review time: 77 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 12 | 12 |
| HAM | Apparatus, Electrosurgical | 4 | 4 |
| DWG | Electrosurgical Device | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Review panels
Most recent Beacon Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930243 | FLEXIBLE EXTENDER | GEI | 1994-03-11 | 416 |
| K930497 | ARGON HANDPIECES | GEI | 1993-06-25 | 144 |
| K925708 | DISPOSABLE ELECTROSURGERY BALL ELECTRODE | DWG | 1993-04-20 | 159 |
| K922289 | SESQUIPOLAR(TM) MIS ELECTRODE | GEI | 1993-01-15 | 245 |
| K925619 | DISPOSABLE HAND-SWITCHING ESU PENCIL | GEI | 1992-12-24 | 48 |
| K915788 | MIS ELECTROSURGICAL ELECTRODES | GEI | 1992-03-13 | 80 |
| K920100 | GSU HANDPIECE ADAPTER | HAM | 1992-02-03 | 25 |
| K913772 | PRESSURE GUARD | HIF | 1991-11-19 | 88 |
| K905752 | ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE | GEI | 1991-07-22 | 210 |
| K904506 | ACTIVE ADAPTER | GEI | 1990-12-13 | 72 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Beacon Laboratories, 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 Beacon Laboratories, Inc. have?
Beacon Laboratories, Inc. has 18 FDA 510(k) clearances (first 1989, latest 1994), across 4 product codes in 2 review panels.
How long does FDA take to clear Beacon Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Beacon Laboratories, Inc.'s cleared 510(k)s is 77 days.
What devices does Beacon Laboratories, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 12); HAM (Apparatus, Electrosurgical, 4); DWG (Electrosurgical Device, 1).
Has Beacon Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Beacon Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 18 Beacon Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Beacon Laboratories, 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.