FDA product code · Cardiovascular · Class 2
DXN: System, Measurement, Blood-Pressure, Non-Invasive
DXN is FDA's product code for "System, Measurement, Blood-Pressure, Non-Invasive": a Class 2 device classified under 21 CFR 870.1130, reviewed by the Cardiovascular panel.
510(k) review time for DXN
Across 235 510(k) clearances under DXN decided from 2018-01-01 to 2026-10-06, the median was 161 days from FDA receipt to decision. Half took between 113 and 241 days, and 80% were decided within 261 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 113 |
| Median | 161 |
| 75th percentile | 241 |
| 80th percentile | 261 |
| 90th percentile | 305 |
| Slowest | 719 |
| Year | Median days | n |
|---|---|---|
| 2018 | 235 | 22 |
| 2019 | 156 | 33 |
| 2020 | 198 | 24 |
| 2021 | 190 | 23 |
| 2022 | 137 | 25 |
| 2023 | 182 | 35 |
| 2024 | 107 | 17 |
| 2025 | 142 | 28 |
| 2026 (to 10-06, partial) | 144 | 28 |
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.
DXN in the public FDA record
| 510(k) clearances, all years | 1,224 |
|---|---|
| Device recalls | 36 |
| Establishment listings | 1,772 |
| GUDID device identifiers | 4,961 |
Counts of records, not of devices or events. Adverse event reports for DXN 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 DXN
7 FDA recognized consensus standards cite DXN, 5 of them recognized only in part, among them IEEE Std 11073-10407-2020; IEC 80601-2-30: Edition 2.0 2018-03; ISO 81060-2 Third edition 2018-11 [Including AMD1:2020]. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-135 IEEE Std 11073-10407-2020 — Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
- 3-123 IEC 80601-2-30: Edition 2.0 2018-03 (partial recognition) — Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- 3-166 ISO 81060-2 Third edition 2018-11 [Including AMD1:2020] (partial recognition) — Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
- 3-167 ISO TS 81060-5 First edition 2020-02 — Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
- 3-168 IEEE Std 1708-2014 (partial recognition) — Standard for Wearable Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
- 3-188 ISO 81060-3 First edition 2022-12 (partial recognition) — Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
- 3-196 ISO 81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024] (partial recognition) — Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)]
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.