FDA product code · Cardiovascular · Class 2
DXQ: Blood Pressure Cuff
DXQ is FDA's product code for "Blood Pressure Cuff": a Class 2 device classified under 21 CFR 870.1120, reviewed by the Cardiovascular panel.
510(k) review time for DXQ
Across 33 510(k) clearances under DXQ decided from 2018-01-01 to 2026-10-06, the median was 102 days from FDA receipt to decision. Half took between 58 and 174 days, and 80% were decided within 192 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 58 |
| Median | 102 |
| 75th percentile | 174 |
| 80th percentile | 192 |
| 90th percentile | 224 |
| Slowest | 323 |
| Year | Median days | n |
|---|---|---|
| 2018 | 225 | 5 |
| 2023 | 79 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
DXQ in the public FDA record
| 510(k) clearances, all years | 199 |
|---|---|
| Device recalls | 27 |
| Establishment listings | 301 |
| GUDID device identifiers | 11,808 |
Counts of records, not of devices or events. Adverse event reports for DXQ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite DXQ
1 FDA recognized consensus standard cite DXQ, among them ISO 81060-1 First edition 2007-12-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-96 ISO 81060-1 First edition 2007-12-01 — Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.