Summit Doppler Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Summit Doppler Systems, Inc.” (first 2003, latest 2011), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| HEK | Monitor, Heart Sound, Fetal, Ultrasonic | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 1 |
| MAA | Monitor, Fetal Doppler Ultrasound | 1 | 1 |
Review panels
- Radiology (4)
- Obstetrics and Gynecology (2)
- Cardiovascular (1)
Most recent Summit Doppler Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103693 | VANTAGE ABI | DXN | 2011-02-15 | 60 |
| K101816 | STN PROBE | ITX | 2010-08-19 | 50 |
| K093393 | LIFEDOP MODEL 300ABI | JAF | 2009-12-24 | 55 |
| K090499 | LIFEDOP MODEL, L350R | MAA | 2009-03-31 | 34 |
| K063600 | VISTA AVS | JAF | 2006-12-19 | 15 |
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | HEK | 2006-04-10 | 53 |
| K024197 | LIFEDOP DOPPLER | KNG | 2003-01-03 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Summit Doppler Systems, 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.
Device clinical trials
An industry sponsor named Summit Doppler Systems, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01165437: Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index (Completed, started 2010-10)
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.
- Summit Medical, Inc. (14 510(k)s)
- Summit World Trade Corp. (10 510(k)s)
- Summit Industries, Inc. (8 510(k)s)
- Summit Nuclear (6 510(k)s)
- Summit Glove, Inc. (5 510(k)s)
- Summit Technology, Inc. (5 510(k)s)
- Summit Medical Products, Inc. (4 510(k)s)
- Summit Medventures (2 510(k)s)
- Summit Optics, Inc. (2 510(k)s)
- Summit Spine (2 510(k)s)
- Summit Access, LLC (1 510(k)s)
- Summit Durable Medical Equipment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Summit Doppler Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Summit Doppler Systems, Inc.” (first 2003, latest 2011), across 6 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 Summit Doppler Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Summit Doppler Systems, Inc. is 50 days.
Which FDA product codes appear under Summit Doppler Systems, Inc.?
The most frequent FDA product codes under this applicant name are JAF (Monitor, Ultrasonic, Nonfetal, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1); HEK (Monitor, Heart Sound, Fetal, Ultrasonic, 1).
Next steps
- See all 7 Summit Doppler Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAF, Summit Doppler Systems, 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.