FDA product code · Orthopedic · Class 2
OLO: Orthopedic Stereotaxic Instrument
OLO is FDA's product code for "Orthopedic Stereotaxic Instrument": a Class 2 device classified under 21 CFR 882.4560, reviewed by the Orthopedic panel.
510(k) review time for OLO
Across 328 510(k) clearances under OLO decided from 2018-01-01 to 2026-10-06, the median was 91 days from FDA receipt to decision. Half took between 59 and 157 days, and 80% were decided within 179 days. These are past clearances, not a forecast for a new submission.
| Fastest | 16 |
|---|---|
| 25th percentile | 59 |
| Median | 91 |
| 75th percentile | 157 |
| 80th percentile | 179 |
| 90th percentile | 248 |
| Slowest | 570 |
| Year | Median days | n |
|---|---|---|
| 2018 | 97 | 24 |
| 2019 | 95 | 35 |
| 2020 | 89 | 34 |
| 2021 | 91 | 28 |
| 2022 | 89 | 40 |
| 2023 | 90 | 45 |
| 2024 | 90 | 44 |
| 2025 | 119 | 40 |
| 2026 (to 10-06, partial) | 111 | 38 |
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.
OLO in the public FDA record
| 510(k) clearances, all years | 440 |
|---|---|
| Device recalls | 113 |
| Establishment listings | 1,899 |
| GUDID device identifiers | 16,253 |
Counts of records, not of devices or events. Adverse event reports for OLO 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 OLO
3 FDA recognized consensus standards cite OLO, among them ASTM F2554-18; ASTM F2554-22; IEC 63145-10 Edition 1.0 2023-09. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-350 ASTM F2554-18 — Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
- 11-415 ASTM F2554-22 — Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
- 12-360 IEC 63145-10 Edition 1.0 2023-09 — Eyewear display - Part 10: Specifications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.