Siemens Healthcare Diagnostics Products GmbH: FDA clearances and approvals
Siemens Healthcare Diagnostics Products GmbH has 23 FDA 510(k) clearances (first 2016, latest 2026), plus 4 PMA and 1 De Novo decisions, across 14 product codes in 4 review panels. Median 510(k) review time: 114 days. Since 2017 its median was 136 days, against 137 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Siemens Healthcare Diagnostics Products GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 5 | 114 |
| 2017 | 3 | 90 |
| 2018 | 2 | 89 |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 4 | 312 |
| 2022 | 2 | 351 |
| 2023 | 3 | 445 |
| 2024 | 2 | 170 |
| 2025 | 0 | — |
| 2026 | 1 | 214 |
Review time against the same product codes
Since 2017, Siemens Healthcare Diagnostics Products GmbH's cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | 6 | 6 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 6 | 6 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 3 | 0 |
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 2 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 1 | 1 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 1 | 1 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 1 | 0 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 1 | 1 |
| MOI | System, Test, Immunological, Antigen, Tumor | 1 | 1 |
Plus 4 more product codes.
Review panels
- Immunology (11)
- Hematology (10)
- Microbiology (4)
- Clinical Chemistry (3)
Most recent Siemens Healthcare Diagnostics Products GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | DHB | 2026-09-04 | 214 |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | QLU | 2024-10-10 | 251 |
| K233946 | IMMULITE® 2000 BR-MA | MOI | 2024-03-13 | 90 |
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | CFN | 2023-12-13 | 28 |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | LTK | 2023-09-08 | 675 |
| K220728 | vWF Ag | GGP | 2023-06-02 | 445 |
| K212559 | CardioPhase® hsCRP | NQD | 2022-12-16 | 490 |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | DFH | 2022-03-02 | 212 |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | DFH | 2021-10-29 | 511 |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | DFH | 2021-07-14 | 621 |
13 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200067 | De Novo | Von Willebrand Factor Assay | 2022-09-29 |
| P010053 | PMA | IMMULITE 2000 XPI ANTI-HBC IMG | 2002-07-26 |
| P010050 | PMA | IMMULITE 2000 XPI HBSAG | 2002-07-26 |
| P010051 | PMA | IMMULITE 2000 XPI ANTI-HBC | 2002-07-24 |
| P010052 | PMA | IMMULITE 2000 XPI ANTI-HBS | 2002-07-22 |
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2026-07-13.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Siemens Healthcare Diagnostics Products GmbH's product codes (a text match, not an official crosswalk):
- J7179 — Injection, von willebrand factor (recombinant), (vonvendi), 1 i.u. vwf:rco (via QTY)
- J7186 — Injection, antihemophilic factor viii/von willebrand factor complex (human), per factor viii i.u. (via QTY)
- J7187 — Injection, von willebrand factor complex (humate-p), per iu vwf:rco (via QTY)
- J7214 — Injection, factor viii/von willebrand factor complex, recombinant (altuviiio), per factor viii i.u. (via QTY)
- J7183 — Injection, von willebrand factor complex (human), wilate, 1 i.u. vwf:rco (via QTY)
Frequently asked questions
How many FDA 510(k) clearances does Siemens Healthcare Diagnostics Products GmbH have?
Siemens Healthcare Diagnostics Products GmbH has 23 FDA 510(k) clearances (first 2016, latest 2026), plus 4 PMA and 1 De Novo decisions, across 14 product codes in 4 review panels.
How long does FDA take to clear Siemens Healthcare Diagnostics Products GmbH's 510(k)s?
The median time from FDA receipt to decision across Siemens Healthcare Diagnostics Products GmbH's cleared 510(k)s is 114 days. Since 2017: 136 days, versus 137 days for all cleared 510(k)s in the same product codes.
What devices does Siemens Healthcare Diagnostics Products GmbH make?
Its most frequent FDA product codes are DFH (Kappa, Antigen, Antiserum, Control, 6); JPA (System, Multipurpose For In Vitro Coagulation Studies, 6); SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays, 3).
Has Siemens Healthcare Diagnostics Products GmbH had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Siemens Healthcare Diagnostics Products GmbH; the most recent began 2026-07-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 23 Siemens Healthcare Diagnostics Products GmbH clearances with predicates and recalls
- Run predicate analysis for product code DFH, Siemens Healthcare Diagnostics Products 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.