Siemens Corp.: FDA filings under this applicant name
FDA lists 67 510(k) clearances under the applicant name “Siemens Corp.” (first 1978, latest 2010), plus 2 PMA decisions, across 35 product codes in 8 review panels. Median 510(k) review time under this name: 34 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 7 | 7 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 6 | 6 |
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
| IZF | System, X-Ray, Tomographic | 4 | 4 |
| IZI | System, X-Ray, Angiographic | 4 | 4 |
| KXJ | Table, Radiologic | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
| DSF | Recorder, Paper Chart | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
Plus 25 more product codes.
Review panels
- Radiology (52)
- Cardiovascular (6)
- Anesthesiology (3)
- Gastroenterology and Urology (2)
- Microbiology (2)
- Neurology (2)
- Clinical Chemistry (1)
- Dental (1)
Most recent Siemens Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL | JIT | 2010-12-17 | 31 |
| K081182 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN | JWY | 2008-08-08 | 105 |
| K993947 | KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY | IZI | 1999-12-21 | 29 |
| K992925 | AX WORKSTATION DR-VIEWER SOFTWARE OPTION | LLZ | 1999-11-23 | 85 |
| K991652 | HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM | LNH | 1999-08-03 | 82 |
| K991600 | SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION | JAK | 1999-06-09 | 30 |
| K984221 | FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR | LNH | 1999-02-12 | 79 |
| K984224 | PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS | LNH | 1999-02-02 | 69 |
| K982536 | PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE | JAK | 1998-11-24 | 126 |
| K963983 | E. CAM PROFILE ATTENUATION CORRECTION | KPS | 1997-03-31 | 178 |
57 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P110041 | PMA | ADVIA CENTAUR HBSAGII | 2014-05-16 |
| P870018 | PMA | LITHOSTAR | 1988-09-30 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Corp..
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 Corp. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
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 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 Corp.?
FDA lists 67 510(k) clearances under the applicant name “Siemens Corp.” (first 1978, latest 2010), plus 2 PMA decisions, across 35 product codes in 8 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 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Corp. is 34 days.
Which FDA product codes appear under Siemens Corp.?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 7); IZO (Generator, High-Voltage, X-Ray, Diagnostic, 6); JAK (System, X-Ray, Tomography, Computed, 5).
Next steps
- See all 67 Siemens Corp. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Siemens Corp.'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.