FDA product code · Orthopedic · Class 2
SBF: Orthopedic Augmented Reality
SBF is FDA's product code for "Orthopedic Augmented Reality": a Class 2 device classified under 21 CFR 882.4560, reviewed by the Orthopedic panel.
510(k) review time for SBF
Across 43 510(k) clearances under SBF decided from 2018-01-01 to 2026-10-06, the median was 111 days from FDA receipt to decision. Half took between 88 and 211 days, and 80% were decided within 223 days. These are past clearances, not a forecast for a new submission.
| Fastest | 21 |
|---|---|
| 25th percentile | 88 |
| Median | 111 |
| 75th percentile | 211 |
| 80th percentile | 223 |
| 90th percentile | 260 |
| Slowest | 404 |
| Year | Median days | n |
|---|---|---|
| 2022 | 234 | 7 |
| 2023 | 104 | 7 |
| 2024 | 89 | 6 |
| 2025 | 90 | 13 |
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.
SBF in the public FDA record
| 510(k) clearances, all years | 43 |
|---|---|
| Establishment listings | 98 |
| GUDID device identifiers | 734 |
Counts of records, not of devices or events. Adverse event reports for SBF 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 SBF
No FDA recognized consensus standard cites SBF 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.