Siemens Healthcare Diagnostics Products, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Siemens Healthcare Diagnostics Products, Ltd.” (first 2021, latest 2026), plus 4 PMA decisions, across 6 product codes in 3 review panels. Median 510(k) review time under this name: 113 days. Since 2017 the median was 113 days, against 132 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 |
|---|---|---|
| 2021 | 2 | 92 |
| 2022 | 0 | — |
| 2023 | 1 | 675 |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 1 | 214 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Siemens Healthcare Diagnostics Products, Ltd. took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 3 | 0 |
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| 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 |
Review panels
- Microbiology (4)
- Immunology (3)
- Clinical Chemistry (2)
Most recent Siemens Healthcare Diagnostics Products, Ltd. 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 |
| K233946 | IMMULITE® 2000 BR-MA | MOI | 2024-03-13 | 90 |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | LTK | 2023-09-08 | 675 |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | CGR | 2021-01-15 | 71 |
| K202826 | IMMULITE® 2000 Cortisol | CGR | 2021-01-15 | 113 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| 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 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.
- 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 Medi Cal Solutions, Inc. (32 510(k)s)
- Siemens AG Medical Solutions (31 510(k)s)
- Siemens Healthcare GmbH (31 510(k)s)
- Siemens Medical Systems, Inc. (25 510(k)s)
- Siemens Healthcare Diagnostics Products GmbH (18 510(k)s)
- Siemens AG (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Healthcare Diagnostics Products, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Siemens Healthcare Diagnostics Products, Ltd.” (first 2021, latest 2026), plus 4 PMA decisions, across 6 product codes in 3 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 Diagnostics Products, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Healthcare Diagnostics Products, Ltd. is 113 days. Since 2017: 113 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Siemens Healthcare Diagnostics Products, Ltd.?
The most frequent FDA product codes under this applicant name are SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays, 3); CGR (Radioimmunoassay, Cortisol, 2); DHB (System, Test, Radioallergosorbent (Rast) Immunological, 1).
Next steps
- See all 5 Siemens Healthcare Diagnostics Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code SEI, Siemens Healthcare Diagnostics Products, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.