Pro Med Instruments GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pro Med Instruments GmbH” (first 2019, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 104 days, against 119 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 90 |
| 2020 | 2 | 204 |
| 2021 | 1 | 119 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 55 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pro Med Instruments GmbH took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 6 | 6 |
Review panels
- Neurology (6)
Most recent Pro Med Instruments GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | HBL | 2024-07-26 | 28 |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | HBL | 2024-04-24 | 82 |
| K203505 | DORO QR3 Headrest System (Aluminum) | HBL | 2021-03-29 | 119 |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | HBL | 2020-06-02 | 174 |
| K191740 | DORO LUCENT® iXI and iMRI Headrest System | HBL | 2020-02-21 | 235 |
| K191979 | DORO QR3 XTom Headholder System | HBL | 2019-10-22 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Pro Med Instruments GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pro Med Instruments GmbH?
FDA lists 6 510(k) clearances under the applicant name “Pro Med Instruments GmbH” (first 2019, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pro Med Instruments GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pro Med Instruments GmbH is 104 days. Since 2017: 104 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pro Med Instruments GmbH?
The most frequent FDA product codes under this applicant name are HBL (Holder, Head, Neurosurgical (Skull Clamp), 6).
Next steps
- See all 6 Pro Med Instruments GmbH clearances with predicates and recalls
- Run predicate analysis for product code HBL, Pro Med Instruments GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.