FDA product code DQD: Stethoscope, Electronic
DQD is the FDA product code for stethoscope, electronic. It is a Class II device, regulated under 21 CFR 870.1875 and reviewed by the Cardiovascular panel. FDA has cleared 156 510(k) submissions under DQD, 30 in the last five years, from 102 different applicants. The average 510(k) review took 140 days (median 120); 134 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Stethoscope, Electronic |
| Device class | Class II |
| Regulation | 21 CFR 870.1875 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DQD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 112 |
| 2018 | 4 | 138 |
| 2019 | 4 | 245 |
| 2020 | 6 | 117 |
| 2021 | 4 | 148 |
| 2022 | 8 | 191 |
| 2023 | 10 | 182 |
| 2024 | 4 | 140 |
| 2025 | 3 | 89 |
| 2026 | 5 | 174 |
Compare with all 510(k) review times · Search every DQD clearance
Top DQD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Company | 6 | 2009-07-15 |
| Eko Devices, Inc. | 5 | 2023-05-26 |
| Chip Ideas Electronics S.L. | 5 | 2022-05-26 |
| Rnk Products, Inc. | 5 | 2013-10-11 |
| Zargis Medical Corp. | 5 | 2009-08-07 |
97 more applicants have DQD clearances. See the full list in Caduvo.
Most recent DQD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261494 | Shanghai Hulu Devices Co., Ltd. | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | 2026-07-31 | 86 |
| K261694 | Eko Health, Inc. | CORE 300 Digital Stethoscope | 2026-07-23 | 62 |
| K252915 | Ai Health Highway India Pvt., Ltd. | AiSteth® | 2026-05-22 | 252 |
| K252089 | Tyto Care , Ltd. | Tyto Stethoscope (G3) | 2026-03-12 | 253 |
| K252076 | Kneevoice, Inc. | Kneevoice Cartilage Evaluation System (750-3600-001) | 2026-02-06 | 219 |
Recalls for DQD devices
openFDA lists no recalls for product code DQD.
Frequently asked questions
What is FDA product code DQD?
DQD is the FDA product code for stethoscope, electronic. It is a Class II device, regulated under 21 CFR 870.1875 and reviewed by the Cardiovascular panel.
What device class is DQD?
Class II, regulation 21 CFR 870.1875. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQD?
Across 156 cleared submissions the average was 140 days from receipt to decision (median 120).
Which companies have the most DQD clearances?
3M Company (6); Eko Devices, Inc. (5); Chip Ideas Electronics S.L. (5); Rnk Products, Inc. (5); Zargis Medical Corp. (5).
Next steps
- Run an FDA pathway report with predicate devices for product code DQD
- Run a recall and safety report across every DQD manufacturer
- Watch product code DQD 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times