Siemens Healthcare Diagnostic Products GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Siemens Healthcare Diagnostic Products GmbH” (first 2016, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 184 days. Since 2017 the median was 164 days, against 194 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.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 301 |
| 2017 | 1 | 143 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 1 | 184 |
| 2026 | 1 | 242 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Siemens Healthcare Diagnostic Products GmbH took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 194 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 2 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 | 1 |
Review panels
- Hematology (4)
- Immunology (1)
Most recent Siemens Healthcare Diagnostic Products GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | DAP | 2026-08-11 | 242 |
| K242952 | INNOVANCE Antithrombin | JBQ | 2025-03-28 | 184 |
| K232624 | CardioPhase® hsCRP | DCN | 2023-11-27 | 90 |
| K172286 | Automated Blood Coagulation Analyzer CS-2500 | JPA | 2017-12-18 | 143 |
| K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | 2016-01-11 | 301 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Healthcare Diagnostic Products 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Siemens Healthcare Diagnostic Products GmbH (a text match, not an official crosswalk):
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.
- Siemens Medical Solutions USA, Inc. (784 510(k)s)
- Siemens Healthcare Diagnostics, Inc. (245 510(k)s)
- Siemens Corp. (67 510(k)s)
- Siemens Elema AB (63 510(k)s)
- Siemens Gammasonics, Inc. (53 510(k)s)
- Siemens Hearing Instruments, Inc. (42 510(k)s)
- Siemens Healthcare GmbH (32 510(k)s)
- Siemens Medi Cal Solutions, Inc. (32 510(k)s)
- Siemens AG Medical Solutions (31 510(k)s)
- Siemens Medical Systems, Inc. (25 510(k)s)
- Siemens Healthcare Diagnostics Products GmbH (23 510(k)s)
- Siemens AG (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Healthcare Diagnostic Products GmbH?
FDA lists 5 510(k) clearances under the applicant name “Siemens Healthcare Diagnostic Products GmbH” (first 2016, latest 2026), across 4 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 Siemens Healthcare Diagnostic Products GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Healthcare Diagnostic Products GmbH is 184 days. Since 2017: 164 days, versus 194 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Siemens Healthcare Diagnostic Products GmbH?
The most frequent FDA product codes under this applicant name are JPA (System, Multipurpose For In Vitro Coagulation Studies, 2); DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, 1); DCN (System, Test, C-Reactive Protein, 1).
Next steps
- See all 5 Siemens Healthcare Diagnostic Products GmbH clearances with predicates and recalls
- Run predicate analysis for product code JPA, Siemens Healthcare Diagnostic Products 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.