FDA product code · Ophthalmic · Class 2
HQC: Unit, Phacofragmentation
HQC is FDA's product code for "Unit, Phacofragmentation": a Class 2 device classified under 21 CFR 886.4670, reviewed by the Ophthalmic panel.
510(k) review time for HQC
Across 24 510(k) clearances under HQC decided from 2018-01-01 to 2026-10-06, the median was 195 days from FDA receipt to decision. Half took between 132 and 266 days, and 80% were decided within 267 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 132 |
| Median | 195 |
| 75th percentile | 266 |
| 80th percentile | 267 |
| 90th percentile | 268 |
| Slowest | 281 |
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.
HQC in the public FDA record
| 510(k) clearances, all years | 316 |
|---|---|
| Device recalls | 74 |
| Establishment listings | 305 |
| GUDID device identifiers | 1,620 |
Counts of records, not of devices or events. Adverse event reports for HQC 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 HQC
2 FDA recognized consensus standards cite HQC, among them IEC 80601-2-58 Edition 2.0 2014-09; IEC 80601-2-58 Edition 3.0 2024-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 10-126 IEC 80601-2-58 Edition 2.0 2014-09 — Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
- 10-136 IEC 80601-2-58 Edition 3.0 2024-03 — Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.