Berchtold Holding GmbH: FDA clearances and approvals
Berchtold Holding GmbH has 16 FDA 510(k) clearances (first 1992, latest 2008), across 5 product codes in 2 review panels. Median 510(k) review time: 55 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | 9 | 9 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| FQO | Table, Operating-Room, Ac-Powered | 2 | 2 |
| KMI | Monitor, Bed Patient | 1 | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 | 1 |
Review panels
Most recent Berchtold Holding GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083066 | CHROMOPHARE E 778 AND E 558 | FSY | 2008-10-30 | 15 |
| K080857 | CHROMOPHARE E-SERIES | FSY | 2008-04-10 | 14 |
| K024132 | CHROMOPHARE X 65 | FSY | 2003-03-21 | 95 |
| K990656 | CHROMOPHARE D 530 LDR SURGICAL LIGHT | FSY | 1999-07-20 | 141 |
| K991527 | CHROMOPHARE D500, D530, D650 | FSY | 1999-05-27 | 24 |
| K974433 | CHROMOPHARE D 500, CHROMOPHARE D 530 | FSY | 1998-02-20 | 88 |
| K965130 | CHROMOPHARE | FSY | 1997-07-14 | 203 |
| K955750 | TELETOM | FQO | 1996-02-08 | 52 |
| K950932 | BIPOLAP HOOK ELECTRODE | GEI | 1995-03-15 | 14 |
| K944855 | CHROMOPHARE | FSY | 1994-10-19 | 19 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Berchtold Holding GmbH.
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 Berchtold Holding GmbH have?
Berchtold Holding GmbH has 16 FDA 510(k) clearances (first 1992, latest 2008), across 5 product codes in 2 review panels.
How long does FDA take to clear Berchtold Holding GmbH's 510(k)s?
The median time from FDA receipt to decision across Berchtold Holding GmbH's cleared 510(k)s is 55 days.
What devices does Berchtold Holding GmbH make?
Its most frequent FDA product codes are FSY (Light, Surgical, Ceiling Mounted, 9); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); FQO (Table, Operating-Room, Ac-Powered, 2).
Has Berchtold Holding GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Berchtold Holding GmbH. Related entities may recall under other names.
Next steps
- See all 16 Berchtold Holding GmbH clearances with predicates and recalls
- Run predicate analysis for product code FSY, Berchtold Holding GmbH'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.