FDA product code · Obstetrics/Gynecology · Class 2
NUC: Lubricant, Personal
NUC is FDA's product code for "Lubricant, Personal": a Class 2 device classified under 21 CFR 884.5300, reviewed by the Obstetrics/Gynecology panel.
510(k) review time for NUC
Across 123 510(k) clearances under NUC decided from 2018-01-01 to 2026-10-06, the median was 141 days from FDA receipt to decision. Half took between 90 and 253 days, and 80% were decided within 263 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 90 |
| Median | 141 |
| 75th percentile | 253 |
| 80th percentile | 263 |
| 90th percentile | 294 |
| Slowest | 493 |
| Year | Median days | n |
|---|---|---|
| 2018 | 114 | 15 |
| 2019 | 150 | 13 |
| 2020 | 180 | 19 |
| 2021 | 143 | 20 |
| 2022 | 112 | 14 |
| 2023 | 159 | 13 |
| 2024 | 178 | 6 |
| 2025 | 221 | 11 |
| 2026 (to 10-06, partial) | 104 | 12 |
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.
NUC in the public FDA record
| 510(k) clearances, all years | 248 |
|---|---|
| Establishment listings | 344 |
| GUDID device identifiers | 1,740 |
Counts of records, not of devices or events. Adverse event reports for NUC 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 NUC
1 FDA recognized consensus standard cite NUC, among them ASTM D7661-18. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 9-145 ASTM D7661-18 — Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.