Siemens Medical Laboratories, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Siemens Medical Laboratories, Inc.” (first 1979, latest 1991), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 9 | 9 |
| DXK | Echocardiograph | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 1 | 1 |
| JAI | Couch, Radiation Therapy, Powered | 1 | 1 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 | 1 |
Review panels
- Radiology (12)
- Cardiovascular (1)
Most recent Siemens Medical Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910971 | Z XT RADIATION THERAPY TREATMENT TABLE | JAI | 1991-05-03 | 57 |
| K903139 | BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743) | IYE | 1990-11-07 | 113 |
| K894230 | PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) | IYE | 1989-08-28 | 70 |
| K882729 | MEVATRON, M 2 CLASS | IYE | 1988-09-19 | 75 |
| K875272 | SONOLINE CF | DXK | 1988-02-18 | 56 |
| K862339 | MEVATRON KD-2 | IYE | 1986-10-29 | 131 |
| K854609 | MEVAMATIC 3 | JAD | 1986-02-21 | 95 |
| K852907 | SIEMENS MEVATRON ME | LHN | 1985-09-19 | 72 |
| K812032 | MEVATRON 67E | IYE | 1981-08-18 | 29 |
| K791967 | MEVATRON 74X MEDICAL LINEAR ACCELERATOR | IYE | 1979-11-16 | 45 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens Medical Laboratories, Inc..
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 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 Medical Laboratories, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Siemens Medical Laboratories, Inc.” (first 1979, latest 1991), across 5 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 Medical Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Medical Laboratories, Inc. is 57 days.
Which FDA product codes appear under Siemens Medical Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 9); DXK (Echocardiograph, 1); JAD (System, Therapeutic, X-Ray, 1).
Next steps
- See all 13 Siemens Medical Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Siemens Medical Laboratories, 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.