FDA product code · Orthopedic · Class 2
HTN: Washer, Bolt Nut
HTN is FDA's product code for "Washer, Bolt Nut": a Class 2 device classified under 21 CFR 888.3030, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for HTN
Across 31 510(k) clearances under HTN decided from 2018-01-01 to 2026-10-06, the median was 92 days from FDA receipt to decision. Half took between 62 and 165 days, and 80% were decided within 198 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 62 |
| Median | 92 |
| 75th percentile | 165 |
| 80th percentile | 198 |
| 90th percentile | 262 |
| Slowest | 279 |
| Year | Median days | n |
|---|---|---|
| 2019 | 116 | 5 |
| 2022 | 86 | 5 |
| 2024 | 90 | 6 |
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.
HTN in the public FDA record
| 510(k) clearances, all years | 93 |
|---|---|
| Establishment listings | 841 |
| GUDID device identifiers | 9,606 |
Counts of records, not of devices or events. Adverse event reports for HTN 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 HTN
4 FDA recognized consensus standards cite HTN, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F983-24. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.