Siemens Healthcare Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 245 510(k) clearances under the applicant name “Siemens Healthcare Diagnostics, Inc.” (first 2008, latest 2026), plus 19 PMA and 1 De Novo decisions, across 105 product codes in 5 review panels. Median 510(k) review time under this name: 109 days. Since 2017 the median was 202 days, against 165 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 |
|---|---|---|
| 2012 | 12 | 76 |
| 2013 | 18 | 80 |
| 2014 | 27 | 49 |
| 2015 | 19 | 164 |
| 2016 | 10 | 171 |
| 2017 | 11 | 151 |
| 2018 | 8 | 222 |
| 2019 | 8 | 58 |
| 2020 | 5 | 70 |
| 2021 | 4 | 524 |
| 2022 | 1 | 207 |
| 2023 | 9 | 347 |
| 2024 | 5 | 90 |
| 2025 | 4 | 262 |
| 2026 | 5 | 245 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Siemens Healthcare Diagnostics, Inc. took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 165 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 34 | 34 |
| JIX | Calibrator, Multi-Analyte Mixture | 12 | 12 |
| JIT | Calibrator, Secondary | 11 | 11 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 10 | 10 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 9 | 9 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 6 | 6 |
| MMI | Immunoassay Method, Troponin Subunit | 6 | 6 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 5 | 5 |
| CEC | Radioimmunoassay, Free Thyroxine | 5 | 5 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 5 | 0 |
Plus 95 more product codes.
Review panels
- Clinical Chemistry (149)
- Immunology (47)
- Microbiology (33)
- Clinical Toxicology (22)
- Hematology (14)
Most recent Siemens Healthcare Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253528 | Atellica IM CA 19-9 II | NIG | 2026-08-10 | 270 |
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | LDP | 2026-07-24 | 88 |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | CIG | 2026-02-27 | 245 |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | JLW | 2026-02-06 | 262 |
| K251630 | Atellica IM Total PSA II (tPSAII) | LTJ | 2026-01-05 | 222 |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | JNL | 2025-12-04 | 261 |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | JZO | 2025-10-17 | 262 |
| K242981 | Atellica IM Thyroglobulin (Tg) | MSW | 2025-06-20 | 267 |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | JLW | 2025-04-25 | 158 |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | CGX | 2024-12-04 | 89 |
235 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250026 | PMA | Atellica IM free PSA II (fPSAII) | 2026-05-11 |
| P240021 | PMA | Atellica IM Total PSA II (tPSAII) | 2025-12-03 |
| P210019 | PMA | ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) | 2022-07-27 |
| DEN190056 | De Novo | Prognostic Test For Assessment Of Liver Related Disease Progression | 2021-08-20 |
| P200017 | PMA | ADVIA Centaur Anti-HBe2 (aHBe2) assay | 2021-07-14 |
Recalls
767 product recalls in 407 recall events; 135 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Siemens Healthcare Diagnostics, Inc. (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 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)
- Siemens Medical Electronics (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Healthcare Diagnostics, Inc.?
FDA lists 245 510(k) clearances under the applicant name “Siemens Healthcare Diagnostics, Inc.” (first 2008, latest 2026), plus 19 PMA and 1 De Novo decisions, across 105 product codes in 5 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Healthcare Diagnostics, Inc. is 109 days. Since 2017: 202 days, versus 165 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Siemens Healthcare Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 34); JIX (Calibrator, Multi-Analyte Mixture, 12); JIT (Calibrator, Secondary, 11).
Next steps
- See all 245 Siemens Healthcare Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Siemens Healthcare Diagnostics, Inc.'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.