FDA product code · Physical Medicine · Class 2
IRP: Massager, Powered Inflatable Tube
IRP is FDA's product code for "Massager, Powered Inflatable Tube": a Class 2 device classified under 21 CFR 890.5650, reviewed by the Physical Medicine panel.
510(k) review time for IRP
Across 100 510(k) clearances under IRP decided from 2018-01-01 to 2026-10-06, the median was 128 days from FDA receipt to decision. Half took between 73 and 233 days, and 80% were decided within 245 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 73 |
| Median | 128 |
| 75th percentile | 233 |
| 80th percentile | 245 |
| 90th percentile | 327 |
| Slowest | 789 |
| Year | Median days | n |
|---|---|---|
| 2019 | 83 | 10 |
| 2020 | 150 | 9 |
| 2021 | 140 | 19 |
| 2022 | 97 | 14 |
| 2023 | 143 | 10 |
| 2024 | 115 | 12 |
| 2025 | 141 | 13 |
| 2026 (to 10-06, partial) | 188 | 10 |
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.
IRP in the public FDA record
| 510(k) clearances, all years | 156 |
|---|---|
| Establishment listings | 202 |
| GUDID device identifiers | 1,206 |
Counts of records, not of devices or events. Adverse event reports for IRP 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 IRP
No FDA recognized consensus standard cites IRP by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.