FDA product code · Neurology · Class 2
OBP: Transcranial Magnetic Stimulator
OBP is FDA's product code for "Transcranial Magnetic Stimulator": a Class 2 device classified under 21 CFR 882.5805, reviewed by the Neurology panel.
510(k) review time for OBP
Across 51 510(k) clearances under OBP decided from 2018-01-01 to 2026-10-06, the median was 158 days from FDA receipt to decision. Half took between 103 and 198 days, and 80% were decided within 212 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 103 |
| Median | 158 |
| 75th percentile | 198 |
| 80th percentile | 212 |
| 90th percentile | 267 |
| Slowest | 679 |
| Year | Median days | n |
|---|---|---|
| 2021 | 132 | 5 |
| 2022 | 168 | 6 |
| 2023 | 119 | 7 |
| 2024 | 266 | 5 |
| 2025 | 125 | 12 |
| 2026 (to 10-06, partial) | 176 | 8 |
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.
OBP in the public FDA record
| 510(k) clearances, all years | 69 |
|---|
Counts of records, not of devices or events. Adverse event reports for OBP 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 OBP
No FDA recognized consensus standard cites OBP 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.