Dolphin Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Dolphin Medical, Inc.” (first 2002, latest 2006), across 1 product code in 1 review panel. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| DQA | Oximeter | 12 | 12 |
Review panels
- Anesthesiology (12)
Most recent Dolphin Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060524 | DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES | DQA | 2006-06-15 | 108 |
| K040380 | DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 | DQA | 2004-08-31 | 196 |
| K033876 | DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 | DQA | 2004-03-11 | 87 |
| K032947 | NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 | DQA | 2003-10-17 | 25 |
| K031465 | MODEL 2100 PULSE OXIMETER | DQA | 2003-10-10 | 155 |
| K030629 | DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER | DQA | 2003-09-04 | 189 |
| K030952 | DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 | DQA | 2003-05-19 | 54 |
| K024235 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER | DQA | 2003-03-17 | 84 |
| K014218 | OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' | DQA | 2002-11-07 | 321 |
| K021959 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 | DQA | 2002-07-11 | 27 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dolphin Medical, 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.
- Dolphin Medical Technologies, Inc. (2 510(k)s)
- Dolphin Imaging Systems (1 510(k)s)
- Dolphin Medical Imaging, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dolphin Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Dolphin Medical, Inc.” (first 2002, latest 2006), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dolphin Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dolphin Medical, Inc. is 98 days.
Which FDA product codes appear under Dolphin Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 12).
Next steps
- See all 12 Dolphin Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Dolphin Medical, 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 (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.