FDA product code DRS: Transducer, Blood-Pressure, Extravascular
DRS is the FDA product code for transducer, blood-pressure, extravascular. It is a Class II device, regulated under 21 CFR 870.2850 and reviewed by the Cardiovascular panel. FDA has cleared 149 510(k) submissions under DRS, 3 in the last five years, from 82 different applicants. The average 510(k) review took 104 days (median 77); 222 days on average over the last three years. FDA has posted 236 recalls for DRS devices, 18 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Blood-Pressure, Extravascular |
| Device class | Class II |
| Regulation | 21 CFR 870.2850 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 139 |
| 2023 | 1 | 269 |
| 2025 | 1 | 178 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every DRS clearance
Top DRS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medex, Inc. | 7 | 1996-06-27 |
| Sorensen Research | 7 | 1983-11-03 |
| Transamerica Delaval, Inc. | 6 | 1986-05-07 |
| Gould, Inc. | 6 | 1986-02-26 |
| Hewlett-Packard Co. | 5 | 1986-06-17 |
77 more applicants have DRS clearances. See the full list in Caduvo.
Most recent DRS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254074 | Procerus Enterprises | TruPress | 2026-09-10 | 266 |
| K242909 | Edwards Lifesciences, LLC | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | 2025-03-21 | 178 |
| K221782 | Merit Medical Pte. , Ltd. | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | 2023-03-17 | 269 |
| K172458 | Smiths Medical Asd, Inc. | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | 2017-11-09 | 87 |
| K163172 | Smiths Medical Asd, Inc. | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | 2017-05-24 | 191 |
Recalls for DRS devices
236 product recalls in 12 recall events; 18 initiated in the last five years and 18 still open. Most recent: 2026-03-24.
| Year | Recalls |
|---|---|
| 2018 | 12 |
| 2021 | 9 |
| 2023 | 15 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code DRS?
DRS is the FDA product code for transducer, blood-pressure, extravascular. It is a Class II device, regulated under 21 CFR 870.2850 and reviewed by the Cardiovascular panel.
What device class is DRS?
Class II, regulation 21 CFR 870.2850. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRS?
Across 149 cleared submissions the average was 104 days from receipt to decision (median 77).
Which companies have the most DRS clearances?
Medex, Inc. (7); Sorensen Research (7); Transamerica Delaval, Inc. (6); Gould, Inc. (6); Hewlett-Packard Co. (5).
Have DRS devices been recalled?
Yes: 236 product recalls across 12 recall events; the most recent began 2026-03-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DRS
- Run a recall and safety report across every DRS manufacturer
- Watch product code DRS 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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