FDA product code · Orthopedic · Class 2
QHE: Shoulder Arthroplasty Implantation System
QHE is FDA's product code for "Shoulder Arthroplasty Implantation System": a Class 2 device classified under 21 CFR 888.3660, reviewed by the Orthopedic panel.
510(k) review time for QHE
Across 26 510(k) clearances under QHE decided from 2018-01-01 to 2026-10-06, the median was 107 days from FDA receipt to decision. Half took between 31 and 177 days, and 80% were decided within 181 days. These are past clearances, not a forecast for a new submission.
| Fastest | 22 |
|---|---|
| 25th percentile | 31 |
| Median | 107 |
| 75th percentile | 177 |
| 80th percentile | 181 |
| 90th percentile | 234 |
| Slowest | 272 |
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.
QHE in the public FDA record
| Establishment listings | 93 |
|---|
Counts of records, not of devices or events. Adverse event reports for QHE 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 QHE
No FDA recognized consensus standard cites QHE by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
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