FDA product code · Radiology · Class 2
KPS: System, Tomography, Computed, Emission
KPS is FDA's product code for "System, Tomography, Computed, Emission": a Class 2 device classified under 21 CFR 892.1200, reviewed by the Radiology panel.
510(k) review time for KPS
Across 89 510(k) clearances under KPS decided from 2018-01-01 to 2026-10-06, the median was 60 days from FDA receipt to decision. Half took between 39 and 96 days, and 80% were decided within 132 days. These are past clearances, not a forecast for a new submission.
| Fastest | 21 |
|---|---|
| 25th percentile | 39 |
| Median | 60 |
| 75th percentile | 96 |
| 80th percentile | 132 |
| 90th percentile | 194 |
| Slowest | 270 |
| Year | Median days | n |
|---|---|---|
| 2018 | 59 | 13 |
| 2020 | 72 | 12 |
| 2021 | 66 | 15 |
| 2022 | 60 | 5 |
| 2023 | 63 | 12 |
| 2024 | 59 | 11 |
| 2025 | 65 | 12 |
| 2026 (to 10-06, partial) | 67 | 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.
KPS in the public FDA record
| 510(k) clearances, all years | 472 |
|---|---|
| Device recalls | 443 |
| Establishment listings | 446 |
Counts of records, not of devices or events. Adverse event reports for KPS 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 KPS
1 FDA recognized consensus standard cite KPS, among them IEEE Std 3333.2.1-2015. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-292 IEEE Std 3333.2.1-2015 — IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.