FDA product code · General Hospital · Class 2
KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KCT is FDA's product code for "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories": a Class 2 device classified under 21 CFR 880.6850, reviewed by the General Hospital panel.
510(k) review time for KCT
Across 112 510(k) clearances under KCT decided from 2018-01-01 to 2026-10-06, the median was 150 days from FDA receipt to decision. Half took between 90 and 260 days, and 80% were decided within 267 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 90 |
| Median | 150 |
| 75th percentile | 260 |
| 80th percentile | 267 |
| 90th percentile | 300 |
| Slowest | 825 |
| Year | Median days | n |
|---|---|---|
| 2018 | 192 | 15 |
| 2019 | 187 | 18 |
| 2020 | 134 | 14 |
| 2021 | 185 | 18 |
| 2022 | 137 | 11 |
| 2023 | 94 | 10 |
| 2024 | 106 | 8 |
| 2025 | 205 | 11 |
| 2026 (to 10-06, partial) | 255 | 7 |
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.
KCT in the public FDA record
| 510(k) clearances, all years | 281 |
|---|---|
| Device recalls | 38 |
| Establishment listings | 848 |
| GUDID device identifiers | 16,088 |
Counts of records, not of devices or events. Adverse event reports for KCT 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 KCT
2 FDA recognized consensus standards cite KCT, 1 of them recognized only in part, among them ANSI AAMI ST77:2013/(R)2018; ISO 17665 First edition 2024-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 14-396 ANSI AAMI ST77:2013/(R)2018 (partial recognition) — Containment devices for reusable medical device sterilization
- 14-601 ISO 17665 First edition 2024-03 — Sterilization of health care products - Moist heat - Requirements for the development validation and routine control of a sterilization process for medical devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.