FDA product code DSK: Computer, Blood-Pressure
DSK is the FDA product code for computer, blood-pressure. It is a Class II device, regulated under 21 CFR 870.1110 and reviewed by the Cardiovascular panel. FDA has cleared 77 510(k) submissions under DSK, 1 in the last five years, from 54 different applicants. The average 510(k) review took 111 days (median 73). FDA has posted 1 recall for DSK devices.
Classification
| Field | Value |
|---|---|
| Device name | Computer, Blood-Pressure |
| Device class | Class II |
| Regulation | 21 CFR 870.1110 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DSK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 156 |
Compare with all 510(k) review times · Search every DSK clearance
Top DSK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A&D Engineering, Inc. | 6 | 1993-02-09 |
| Applied Medical Research | 5 | 1979-02-23 |
| Honeywell, Inc. | 4 | 1981-02-25 |
| Datex Division Instrumentarium Corp. | 3 | 1994-07-27 |
| Radi Medical Systems AB | 2 | 2001-12-18 |
49 more applicants have DSK clearances. See the full list in Caduvo.
Most recent DSK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231586 | Endophys Technologies, LLC | Endophys Blood Pressure Monitor model BPM-30 | 2023-11-03 | 156 |
| K160945 | Endophys Holdings, LLC | Endophys Blood Pressure Monitor | 2016-09-26 | 174 |
| K152582 | Volcano Corporation | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | 2015-12-03 | 84 |
| K141615 | Endophys, Inc. | ENDOPHYS BLOOD PRESSURE MONITOR | 2015-01-07 | 205 |
| K080670 | Atcor Medical | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | 2008-04-23 | 44 |
Recalls for DSK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-05-04.
Frequently asked questions
What is FDA product code DSK?
DSK is the FDA product code for computer, blood-pressure. It is a Class II device, regulated under 21 CFR 870.1110 and reviewed by the Cardiovascular panel.
What device class is DSK?
Class II, regulation 21 CFR 870.1110. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSK?
Across 77 cleared submissions the average was 111 days from receipt to decision (median 73).
Which companies have the most DSK clearances?
A&D Engineering, Inc. (6); Applied Medical Research (5); Honeywell, Inc. (4); Datex Division Instrumentarium Corp. (3); Radi Medical Systems AB (2).
Have DSK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-05-04.
Next steps
- Run an FDA pathway report with predicate devices for product code DSK
- Run a recall and safety report across every DSK manufacturer
- Watch product code DSK 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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