FDA product code DPW: Flowmeter, Blood, Cardiovascular
DPW is the FDA product code for flowmeter, blood, cardiovascular. It is a Class II device, regulated under 21 CFR 870.2100 and reviewed by the Cardiovascular panel. FDA has cleared 138 510(k) submissions under DPW, 10 in the last five years, from 85 different applicants. The average 510(k) review took 165 days (median 124); 127 days on average over the last three years. FDA has posted 35 recalls for DPW devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Flowmeter, Blood, Cardiovascular |
| Device class | Class II |
| Regulation | 21 CFR 870.2100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DPW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 266 |
| 2019 | 3 | 152 |
| 2020 | 2 | 60 |
| 2021 | 2 | 175 |
| 2022 | 3 | 168 |
| 2023 | 1 | 132 |
| 2024 | 1 | 88 |
| 2025 | 3 | 114 |
| 2026 | 2 | 180 |
Compare with all 510(k) review times · Search every DPW clearance
Top DPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Koven Technology, Inc. | 7 | 2021-01-05 |
| Transonic Systems, Inc. | 5 | 2015-07-23 |
| Koven and Assoc., Inc. | 5 | 1993-01-29 |
| Flosonics Medical | 4 | 2026-04-24 |
| Remington Medical, Inc. | 4 | 2025-11-20 |
80 more applicants have DPW clearances. See the full list in Caduvo.
Most recent DPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260700 | BlueDop Medical, Ltd. | BlueDop Vascular Expert | 2026-07-08 | 126 |
| K252810 | Flosonics Medical | FloPatch FP120 | 2026-04-24 | 233 |
| K251904 | Remington Medical, Inc. | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | 2025-11-20 | 153 |
| K251114 | Flosonics Medical | FloPatch FP120 | 2025-06-20 | 70 |
| K243852 | Elfi-Tech , Ltd. | Elfor-L | 2025-04-14 | 119 |
Recalls for DPW devices
35 product recalls in 15 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-03-04.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DPW?
DPW is the FDA product code for flowmeter, blood, cardiovascular. It is a Class II device, regulated under 21 CFR 870.2100 and reviewed by the Cardiovascular panel.
What device class is DPW?
Class II, regulation 21 CFR 870.2100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPW?
Across 138 cleared submissions the average was 165 days from receipt to decision (median 124).
Which companies have the most DPW clearances?
Koven Technology, Inc. (7); Transonic Systems, Inc. (5); Koven and Assoc., Inc. (5); Flosonics Medical (4); Remington Medical, Inc. (4).
Have DPW devices been recalled?
Yes: 35 product recalls across 15 recall events; the most recent began 2026-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code DPW
- Run a recall and safety report across every DPW manufacturer
- Watch product code DPW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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