PAJUNK GmbH Medizintechnologie: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “PAJUNK GmbH Medizintechnologie” (first 2006, latest 2025), across 16 product codes in 8 review panels. Median 510(k) review time under this name: 122 days. Since 2017 the median was 142 days, against 111 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 |
|---|---|---|
| 2012 | 2 | 110 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 5 | 267 |
| 2017 | 3 | 163 |
| 2018 | 1 | 231 |
| 2019 | 2 | 92 |
| 2020 | 1 | 104 |
| 2021 | 0 | — |
| 2022 | 1 | 142 |
| 2023 | 2 | 142 |
| 2024 | 2 | 106 |
| 2025 | 4 | 170 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name PAJUNK GmbH Medizintechnologie took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 13 | 13 |
| CAZ | Anesthesia Conduction Kit | 8 | 8 |
| BSO | Catheter, Conduction, Anesthetic | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| HAW | Neurological Stereotaxic Instrument | 3 | 3 |
| BXN | Stimulator, Nerve, Battery-Powered | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| KNW | Instrument, Biopsy | 2 | 2 |
| BSN | Filter, Conduction, Anesthetic | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Plus 6 more product codes.
Review panels
- Anesthesiology (27)
- General and Plastic Surgery (8)
- Neurology (4)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
Most recent PAJUNK GmbH Medizintechnologie 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243690 | SonoMSK | BSP | 2025-07-01 | 214 |
| K243682 | SonoPlex STIM; SonoPlex II | BSP | 2025-06-27 | 210 |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | BSP | 2025-06-25 | 103 |
| K243525 | SonoTAP and SonoTAP II | BSP | 2025-03-24 | 130 |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | BSP | 2024-11-22 | 142 |
| K241954 | SonoBlock; SonoBlock II | BSP | 2024-09-11 | 70 |
| K230701 | Stim2Go | IPF | 2023-11-24 | 255 |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | HAW | 2023-02-22 | 28 |
| K220897 | Disposable Brain Biopsy Needle 2.0 | HAW | 2022-08-17 | 142 |
| K202699 | E-Cath STIM acc. Tsui | CAZ | 2020-12-29 | 104 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named PAJUNK GmbH Medizintechnologie.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pajunk GmbH (19 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under PAJUNK GmbH Medizintechnologie?
FDA lists 44 510(k) clearances under the applicant name “PAJUNK GmbH Medizintechnologie” (first 2006, latest 2025), across 16 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by PAJUNK GmbH Medizintechnologie?
The median time from FDA receipt to decision across 510(k)s cleared under the name PAJUNK GmbH Medizintechnologie is 122 days. Since 2017: 142 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under PAJUNK GmbH Medizintechnologie?
The most frequent FDA product codes under this applicant name are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 13); CAZ (Anesthesia Conduction Kit, 8); BSO (Catheter, Conduction, Anesthetic, 3).
Next steps
- See all 44 PAJUNK GmbH Medizintechnologie clearances with predicates and recalls
- Run predicate analysis for product code BSP, PAJUNK GmbH Medizintechnologie'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.