FDA product code DXQ: Blood Pressure Cuff
DXQ is the FDA product code for blood pressure cuff. It is a Class II device, regulated under 21 CFR 870.1120 and reviewed by the Cardiovascular panel. FDA has cleared 199 510(k) submissions under DXQ, 18 in the last five years, from 138 different applicants. The average 510(k) review took 100 days (median 81); 106 days on average over the last three years. FDA has posted 27 recalls for DXQ devices, 8 initiated in the last five years.
Definition
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Classification
| Field | Value |
|---|---|
| Device name | Blood Pressure Cuff |
| Device class | Class II |
| Regulation | 21 CFR 870.1120 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 114 |
| 2018 | 5 | 183 |
| 2019 | 3 | 73 |
| 2020 | 3 | 172 |
| 2021 | 4 | 106 |
| 2022 | 4 | 146 |
| 2023 | 5 | 73 |
| 2024 | 2 | 58 |
| 2025 | 3 | 157 |
| 2026 | 4 | 102 |
Compare with all 510(k) review times · Search every DXQ clearance
Top DXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rudolf Riester GmbH & Co. KG | 8 | 2000-12-21 |
| Conphar, Inc. | 6 | 1982-01-22 |
| Pymah Corp. | 5 | 1993-11-24 |
| Abco Dealers, Inc. | 5 | 1982-05-25 |
| Unimed Medical Supplies, Inc. | 4 | 2026-01-09 |
133 more applicants have DXQ clearances. See the full list in Caduvo.
Most recent DXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254287 | Medline Industries, LP | Medline Reusable Blood Pressure Cuff | 2026-06-22 | 173 |
| K260747 | Nihon Kohden Corporation | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | 2026-05-06 | 61 |
| K253089 | Shenzhen Best Electronics Co., Ltd. | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | 2026-02-13 | 143 |
| K253964 | Unimed Medical Supplies, Inc. | Disposable Neonatal NIBP Cuff (U1681S-C51N) | 2026-01-09 | 29 |
| K251745 | Baxter Healthcare Corporation | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | 2025-12-16 | 193 |
Recalls for DXQ devices
27 product recalls in 11 recall events; 8 initiated in the last five years and 7 still open. Most recent: 2025-10-28.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code DXQ?
DXQ is the FDA product code for blood pressure cuff. It is a Class II device, regulated under 21 CFR 870.1120 and reviewed by the Cardiovascular panel.
What device class is DXQ?
Class II, regulation 21 CFR 870.1120. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXQ?
Across 199 cleared submissions the average was 100 days from receipt to decision (median 81).
Which companies have the most DXQ clearances?
Rudolf Riester GmbH & Co. KG (8); Conphar, Inc. (6); Pymah Corp. (5); Abco Dealers, Inc. (5); Unimed Medical Supplies, Inc. (4).
Have DXQ devices been recalled?
Yes: 27 product recalls across 11 recall events; the most recent began 2025-10-28.
Next steps
- Run an FDA pathway report with predicate devices for product code DXQ
- Run a recall and safety report across every DXQ manufacturer
- Watch product code DXQ 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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