FDA product code DQK: Computer, Diagnostic, Programmable
DQK is the FDA product code for computer, diagnostic, programmable. It is a Class II device, regulated under 21 CFR 870.1425 and reviewed by the Cardiovascular panel. FDA has cleared 438 510(k) submissions under DQK, 96 in the last five years, from 193 different applicants. The average 510(k) review took 141 days (median 104); 129 days on average over the last three years. FDA has posted 125 recalls for DQK devices, 46 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Computer, Diagnostic, Programmable |
| Device class | Class II |
| Regulation | 21 CFR 870.1425 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DQK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 144 |
| 2018 | 14 | 151 |
| 2019 | 15 | 135 |
| 2020 | 16 | 137 |
| 2021 | 16 | 157 |
| 2022 | 19 | 218 |
| 2023 | 21 | 126 |
| 2024 | 13 | 122 |
| 2025 | 22 | 98 |
| 2026 | 21 | 167 |
Compare with all 510(k) review times · Search every DQK clearance
Top DQK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosense Webster, Inc. | 34 | 2026-02-20 |
| St Jude Medical | 23 | 2018-04-23 |
| ABBOTT MEDICAL | 12 | 2026-04-20 |
| Edwards Lifesciences, LLC | 12 | 2026-02-24 |
| Acutus Medical, Inc. | 12 | 2023-07-10 |
188 more applicants have DQK clearances. See the full list in Caduvo.
Most recent DQK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261729 | Abbott Medical | EnSite X EP System | 2026-09-17 | 114 |
| K262005 | Medtronic, Inc. | Affera Integrated Mapping System | 2026-08-21 | 67 |
| K253692 | Boston Scientific | AVVIGO+ Multi-Modality Guidance System | 2026-08-21 | 273 |
| K253576 | Analytics For Life, Inc. | CorVista System® with PCWP Add-On | 2026-07-26 | 251 |
| K262006 | Abbott Medical | EnSite X EP System | 2026-07-15 | 30 |
Recalls for DQK devices
125 product recalls in 89 recall events; 46 initiated in the last five years and 47 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 9 |
| 2019 | 7 |
| 2020 | 4 |
| 2021 | 8 |
| 2022 | 7 |
| 2023 | 4 |
| 2024 | 29 |
| 2025 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code DQK?
DQK is the FDA product code for computer, diagnostic, programmable. It is a Class II device, regulated under 21 CFR 870.1425 and reviewed by the Cardiovascular panel.
What device class is DQK?
Class II, regulation 21 CFR 870.1425. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQK?
Across 438 cleared submissions the average was 141 days from receipt to decision (median 104).
Which companies have the most DQK clearances?
Biosense Webster, Inc. (34); St Jude Medical (23); ABBOTT MEDICAL (12); Edwards Lifesciences, LLC (12); Acutus Medical, Inc. (12).
Have DQK devices been recalled?
Yes: 125 product recalls across 89 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code DQK
- Run a recall and safety report across every DQK manufacturer
- Watch product code DQK 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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