Ulrich GmbH & Co. KG: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Ulrich GmbH & Co. KG” (first 2005, latest 2025), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 172 days. Since 2017 the median was 149 days, against 87 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 | 149 |
| 2013 | 2 | 180 |
| 2014 | 0 | — |
| 2015 | 1 | 196 |
| 2016 | 2 | 218 |
| 2017 | 1 | 182 |
| 2018 | 0 | — |
| 2019 | 1 | 87 |
| 2020 | 2 | 153 |
| 2021 | 1 | 163 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 104 |
| 2025 | 2 | 158 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ulrich GmbH & Co. KG took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 87 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZQ | Injector, Contrast Medium, Automatic | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NKG | Posterior Cervical Screw System | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| PQH | Iodinated Contrast Media Transfer Tubing Set | 1 | 1 |
Review panels
- Orthopedic (16)
- General Hospital (8)
Most recent Ulrich GmbH & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | IZQ | 2025-11-18 | 119 |
| K251295 | ulrichINJECT CT Motion (XD 8000) | IZQ | 2025-11-07 | 196 |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | IZQ | 2024-08-26 | 60 |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | IZQ | 2024-04-19 | 149 |
| K210541 | ulrichINJECT CT motion | IZQ | 2021-08-06 | 163 |
| K202227 | Artus cervical plate system | KWQ | 2020-09-14 | 38 |
| K192872 | ulrichINJECT CT Motion | IZQ | 2020-07-02 | 268 |
| K192117 | Small VBR | MQP | 2019-11-01 | 87 |
| K171392 | ulrichINJECT CT motion | IZQ | 2017-11-09 | 182 |
| K161032 | neon3 universal OCT spinal stabilization | NKG | 2016-12-22 | 253 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ulrich GmbH & Co. KG.
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.
- Ulrich Medical USA (12 510(k)s)
- Ulrich Alber GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ulrich GmbH & Co. KG?
FDA lists 24 510(k) clearances under the applicant name “Ulrich GmbH & Co. KG” (first 2005, latest 2025), across 10 product codes in 2 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 Ulrich GmbH & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ulrich GmbH & Co. KG is 172 days. Since 2017: 149 days, versus 87 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ulrich GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are IZQ (Injector, Contrast Medium, Automatic, 7); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3); MQP (Spinal Vertebral Body Replacement Device, 3).
Next steps
- See all 24 Ulrich GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code IZQ, Ulrich GmbH & Co. KG'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.