Siemens Burdick, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Siemens Burdick, Inc.” (first 1991, latest 1992), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 161 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 |
|---|---|---|---|
| LOS | 4 | 4 | |
| IOL | Treadmill, Powered | 2 | 2 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- Physical Medicine (2)
- Cardiovascular (1)
Most recent Siemens Burdick, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915327 | ELITE II ELECTROCARDIOGRAPH,MODIFIED | LOS | 1992-10-09 | 318 |
| K915225 | MEGACART | LOS | 1992-07-01 | 224 |
| K915202 | INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH | LOS | 1992-05-15 | 179 |
| K914969 | E350I ELECTROCARDIOGRAPH | LOS | 1992-03-26 | 142 |
| K913518 | TA620 TREADMILL CONTROLLER | IOL | 1991-10-24 | 78 |
| K910634 | DC200 DEFIBRILLATOR | LDD | 1991-07-24 | 161 |
| K910867 | T600 TREADMILL | IOL | 1991-05-31 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Burdick, 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 Burdick, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Siemens Burdick, Inc.” (first 1991, latest 1992), across 3 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 Burdick, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Burdick, Inc. is 161 days.
Which FDA product codes appear under Siemens Burdick, Inc.?
The most frequent FDA product codes under this applicant name are LOS (device, 4); IOL (Treadmill, Powered, 2); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 1).
Next steps
- See all 7 Siemens Burdick, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOS, Siemens Burdick, 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.