FDA product code · Cardiovascular · Class 2
OWQ: Reprocessed Intravascular Ultrasound Catheter
OWQ is FDA's product code for "Reprocessed Intravascular Ultrasound Catheter": a Class 2 device classified under 21 CFR 870.1200, reviewed by the Cardiovascular panel.
510(k) review time for OWQ
Across 20 510(k) clearances under OWQ decided from 2018-01-01 to 2026-10-06, the median was 145 days from FDA receipt to decision. Half took between 91 and 207 days, and 80% were decided within 260 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 91 |
| Median | 145 |
| 75th percentile | 207 |
| 80th percentile | 260 |
| 90th percentile | 263 |
| Slowest | 447 |
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.
OWQ in the public FDA record
| Device recalls | 10 |
|---|
Counts of records, not of devices or events. Adverse event reports for OWQ 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 OWQ
2 FDA recognized consensus standards cite OWQ, among them IEC 61161 Edition 3.0 2013-01; AAMI TIR42:2021. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-275 IEC 61161 Edition 3.0 2013-01 — Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
- 3-172 AAMI TIR42:2021 — Evaluation of Particulates Associated with Vascular Medical Devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.