FDA product code · Dental · Class 2
LRK: Device, Anti-Snoring
LRK is FDA's product code for "Device, Anti-Snoring": a Class 2 device classified under 21 CFR 872.5570, reviewed by the Dental panel.
510(k) review time for LRK
Across 82 510(k) clearances under LRK decided from 2018-01-01 to 2026-10-06, the median was 149 days from FDA receipt to decision. Half took between 90 and 214 days, and 80% were decided within 238 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 90 |
| Median | 149 |
| 75th percentile | 214 |
| 80th percentile | 238 |
| 90th percentile | 270 |
| Slowest | 529 |
| Year | Median days | n |
|---|---|---|
| 2018 | 200 | 10 |
| 2019 | 150 | 13 |
| 2020 | 80 | 5 |
| 2021 | 126 | 10 |
| 2022 | 154 | 11 |
| 2023 | 156 | 5 |
| 2024 | 254 | 6 |
| 2025 | 107 | 14 |
| 2026 (to 10-06, partial) | 61 | 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.
LRK in the public FDA record
| 510(k) clearances, all years | 215 |
|---|---|
| Device recalls | 10 |
| Establishment listings | 274 |
| GUDID device identifiers | 593 |
Counts of records, not of devices or events. Adverse event reports for LRK 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 LRK
6 FDA recognized consensus standards cite LRK, among them ISO 20795-2 Second edition 2013-03-01; ISO 7405 Third edition 2018-10 Corrected version 2018-12; ISO 15841 Second edition 2014-08. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-233 ISO 20795-2 Second edition 2013-03-01 — Dentistry - Base polymers - Part 2: Orthodontic base polymers
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-268 ISO 15841 Second edition 2014-08 — Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
- 4-294 ANSI ADA Standard No. 139-2020 — Dental Base Polymers
- 4-295 ANSI ADA Standard No. 41-2020 — Evaluation of Biocompatibility of Medical Devices Used in Dentistry
- 4-356 ANSI ADA Standard No. 32-2024 — Dentistry - Orthodontic Wires
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.