FDA product code · General, Plastic Surgery · Class 2
NAY: System, Surgical, Computer Controlled Instrument
NAY is FDA's product code for "System, Surgical, Computer Controlled Instrument": a Class 2 device classified under 21 CFR 876.1500, reviewed by the General, Plastic Surgery panel.
510(k) review time for NAY
Across 87 510(k) clearances under NAY decided from 2018-01-01 to 2026-10-06, the median was 100 days from FDA receipt to decision. Half took between 61 and 172 days, and 80% were decided within 193 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 61 |
| Median | 100 |
| 75th percentile | 172 |
| 80th percentile | 193 |
| 90th percentile | 229 |
| Slowest | 511 |
| Year | Median days | n |
|---|---|---|
| 2018 | 152 | 15 |
| 2019 | 73 | 8 |
| 2020 | 212 | 9 |
| 2021 | 61 | 11 |
| 2022 | 57 | 6 |
| 2023 | 141 | 5 |
| 2024 | 126 | 10 |
| 2025 | 117 | 16 |
| 2026 (to 10-06, partial) | 89 | 7 |
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.
NAY in the public FDA record
| 510(k) clearances, all years | 165 |
|---|---|
| Device recalls | 248 |
| Establishment listings | 2,768 |
| GUDID device identifiers | 586 |
Counts of records, not of devices or events. Adverse event reports for NAY 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 NAY
2 FDA recognized consensus standards cite NAY, among them IEEE Std 3333.2.1-2015; IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-292 IEEE Std 3333.2.1-2015 — IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
- 6-510 IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.