Siemens Medical Electronics: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Siemens Medical Electronics” (first 1988, latest 1995), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 147 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DPS | Electrocardiograph | 4 | 4 |
| DQA | Oximeter | 2 | 2 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| LDQ | 1 | 1 | |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
Most recent Siemens Medical Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935043 | SIEMENS CLINICAL WORK STATION | DQK | 1995-04-07 | 533 |
| K921930 | SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI | DPS | 1993-05-07 | 378 |
| K920445 | SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES | MHX | 1993-03-02 | 392 |
| K914765 | SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS | DXN | 1992-11-06 | 381 |
| K912070 | SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT | GEI | 1992-04-23 | 349 |
| K913489 | SIEMENS MICRO2 PULSE OXIMETER | DQA | 1991-10-30 | 85 |
| K905775 | SIEMENS ETCO2 CARTRIDGE | CCK | 1991-03-11 | 74 |
| K900319 | SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM | DSI | 1990-06-28 | 156 |
| K901771 | SIEMENS SIRECUST 732, PATIENT MONITOR | DPS | 1990-05-30 | 41 |
| K894460 | SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA | DSI | 1989-10-02 | 76 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens Medical Electronics.
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 Medical Electronics?
FDA lists 15 510(k) clearances under the applicant name “Siemens Medical Electronics” (first 1988, latest 1995), across 10 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 Medical Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Medical Electronics is 147 days.
Which FDA product codes appear under Siemens Medical Electronics?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 4); DQA (Oximeter, 2); DSI (Detector And Alarm, Arrhythmia, 2).
Next steps
- See all 15 Siemens Medical Electronics clearances with predicates and recalls
- Run predicate analysis for product code DPS, Siemens Medical Electronics'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.