FDA product code DPT: Probe, Blood-Flow, Extravascular
DPT is the FDA product code for probe, blood-flow, extravascular. It is a Class II device, regulated under 21 CFR 870.2120 and reviewed by the Cardiovascular panel. FDA has cleared 48 510(k) submissions under DPT, 1 in the last five years, from 33 different applicants. The average 510(k) review took 183 days (median 138); 245 days on average over the last three years. FDA has posted 24 recalls for DPT devices, 22 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Probe, Blood-Flow, Extravascular |
| Device class | Class II |
| Regulation | 21 CFR 870.2120 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DPT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 262 |
| 2024 | 1 | 245 |
Compare with all 510(k) review times · Search every DPT clearance
Top DPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Moor Instruments, Ltd. | 8 | 2016-05-12 |
| Vasamedics, LLC | 3 | 1997-04-09 |
| Hewlett-Packard Co. | 3 | 1991-11-07 |
| Spectralmd, Inc. | 2 | 2017-08-17 |
| Deltex Medical Limited | 2 | 2015-01-22 |
28 more applicants have DPT clearances. See the full list in Caduvo.
Most recent DPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233076 | Rwd Life Science Co., Ltd. | Laser Speckle Imaging System (RFLSI CZW) | 2024-05-28 | 245 |
| K163339 | Spectralmd, Inc. | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | 2017-08-17 | 262 |
| K152749 | Moor Instruments, Ltd. | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager | 2016-05-12 | 232 |
| K142932 | Deltex Medical Limited | Deltex Medical KDP72 Doppler Probe | 2015-01-22 | 105 |
| K132730 | Medtronic, Inc. | BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE | 2014-05-30 | 269 |
Recalls for DPT devices
24 product recalls in 3 recall events; 22 initiated in the last five years and 22 still open. Most recent: 2024-09-24.
| Year | Recalls |
|---|---|
| 2024 | 22 |
Frequently asked questions
What is FDA product code DPT?
DPT is the FDA product code for probe, blood-flow, extravascular. It is a Class II device, regulated under 21 CFR 870.2120 and reviewed by the Cardiovascular panel.
What device class is DPT?
Class II, regulation 21 CFR 870.2120. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPT?
Across 48 cleared submissions the average was 183 days from receipt to decision (median 138).
Which companies have the most DPT clearances?
Moor Instruments, Ltd. (8); Vasamedics, LLC (3); Hewlett-Packard Co. (3); Spectralmd, Inc. (2); Deltex Medical Limited (2).
Have DPT devices been recalled?
Yes: 24 product recalls across 3 recall events; the most recent began 2024-09-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DPT
- Run a recall and safety report across every DPT manufacturer
- Watch product code DPT 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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