FDA product code · Ophthalmic · Class 2
HKY: Tonometer, Manual
HKY is FDA's product code for "Tonometer, Manual": a Class 2 device classified under 21 CFR 886.1930, reviewed by the Ophthalmic panel.
510(k) review time for HKY
Across 13 510(k) clearances under HKY decided from 2018-01-01 to 2026-10-06, the median was 128 days from FDA receipt to decision. Half took between 77 and 197 days, and 80% were decided within 210 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 77 |
| Median | 128 |
| 75th percentile | 197 |
| 80th percentile | 210 |
| 90th percentile | 257 |
| Slowest | 335 |
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.
HKY in the public FDA record
| 510(k) clearances, all years | 56 |
|---|---|
| Establishment listings | 106 |
Counts of records, not of devices or events. Adverse event reports for HKY 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 HKY
1 FDA recognized consensus standard cite HKY, 1 of them recognized only in part, among them ANSI Z80.10-2014. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 10-96 ANSI Z80.10-2014 (partial recognition) — American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.