FDA product code · Cardiovascular · Class 2
DXO: Transducer, Pressure, Catheter Tip
DXO is FDA's product code for "Transducer, Pressure, Catheter Tip": a Class 2 device classified under 21 CFR 870.2870, reviewed by the Cardiovascular panel.
510(k) review time for DXO
Across 11 510(k) clearances under DXO decided from 2018-01-01 to 2026-10-06, the median was 142 days from FDA receipt to decision. Half took between 81 and 197 days, and 80% were decided within 219 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 81 |
| Median | 142 |
| 75th percentile | 197 |
| 80th percentile | 219 |
| 90th percentile | 260 |
| Slowest | 268 |
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.
DXO in the public FDA record
| 510(k) clearances, all years | 64 |
|---|---|
| Device recalls | 10 |
| Establishment listings | 118 |
| GUDID device identifiers | 791 |
Counts of records, not of devices or events. Adverse event reports for DXO 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 DXO
3 FDA recognized consensus standards cite DXO, among them IEC 60601-2-34 Edition 3.0 2011-05; IEC 60601-2-34 Edition 4.0 2024-10; ANSI AAMI BP22:1994 (R2016). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-115 IEC 60601-2-34 Edition 3.0 2011-05 — Medical electrical equipment - Part 2-34: Particular requirements for the basic safety including essential performance of invasive blood pressure monitoring equipment
- 3-202 IEC 60601-2-34 Edition 4.0 2024-10 — Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- 3-44 ANSI AAMI BP22:1994 (R2016) — Blood pressure transducers
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.