FDA product code · Ophthalmic · Class 2
HKI: Camera, Ophthalmic, Ac-Powered
HKI is FDA's product code for "Camera, Ophthalmic, Ac-Powered": a Class 2 device classified under 21 CFR 886.1120, reviewed by the Ophthalmic panel.
510(k) review time for HKI
Across 34 510(k) clearances under HKI decided from 2018-01-01 to 2026-10-06, the median was 135 days from FDA receipt to decision. Half took between 80 and 213 days, and 80% were decided within 259 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 80 |
| Median | 135 |
| 75th percentile | 213 |
| 80th percentile | 259 |
| 90th percentile | 268 |
| Slowest | 292 |
| Year | Median days | n |
|---|---|---|
| 2018 | 71 | 6 |
| 2020 | 182 | 5 |
| 2023 | 259 | 5 |
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.
HKI in the public FDA record
| 510(k) clearances, all years | 157 |
|---|---|
| Device recalls | 9 |
| Establishment listings | 170 |
Counts of records, not of devices or events. Adverse event reports for HKI 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 HKI
5 FDA recognized consensus standards cite HKI, 2 of them recognized only in part, among them ISO 15004-1 Second edition 2020-5; ANSI Z80.36-2021; ISO 10940 Second edition 2009-08-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 10-123 ISO 15004-1 Second edition 2020-5 (partial recognition) — Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
- 10-130 ANSI Z80.36-2021 — American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
- 10-74 ISO 10940 Second edition 2009-08-01 (partial recognition) — Ophthalmic instruments - Fundus cameras
- 12-363 NEMA PS 3.1 - 3.20 2024e — Digital Imaging and Communications in Medicine (DICOM) Set
- 12-385 NEMA PS 3.1 - 3.20 2025d — Digital Imaging and Communications in Medicine (DICOM) Set
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.