FDA product code · Cardiovascular · Class 2
OBJ: Catheter, Ultrasound, Intravascular
OBJ is FDA's product code for "Catheter, Ultrasound, Intravascular": a Class 2 device classified under 21 CFR 870.1200, reviewed by the Cardiovascular panel.
510(k) review time for OBJ
Across 30 510(k) clearances under OBJ decided from 2018-01-01 to 2026-10-06, the median was 66 days from FDA receipt to decision. Half took between 29 and 143 days, and 80% were decided within 157 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 29 |
| Median | 66 |
| 75th percentile | 143 |
| 80th percentile | 157 |
| 90th percentile | 206 |
| Slowest | 275 |
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.
OBJ in the public FDA record
| 510(k) clearances, all years | 79 |
|---|---|
| Device recalls | 23 |
| Establishment listings | 370 |
Counts of records, not of devices or events. Adverse event reports for OBJ 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 OBJ
1 FDA recognized consensus standard cite OBJ, among them IEC 61161 Edition 3.0 2013-01. 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
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.