FDA product code KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KCT is the FDA product code for sterilization wrap containers, trays, cassettes & other accessories. It is a Class II device, regulated under 21 CFR 880.6850 and reviewed by the General Hospital panel. FDA has cleared 282 510(k) submissions under KCT, 47 in the last five years, from 158 different applicants. The average 510(k) review took 186 days (median 150); 175 days on average over the last three years. FDA has posted 38 recalls for KCT devices, 25 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class II |
| Regulation | 21 CFR 880.6850 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KCT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 10 | 205 |
| 2018 | 15 | 214 |
| 2019 | 18 | 196 |
| 2020 | 14 | 200 |
| 2021 | 18 | 189 |
| 2022 | 11 | 192 |
| 2023 | 10 | 111 |
| 2024 | 8 | 155 |
| 2025 | 11 | 182 |
| 2026 | 7 | 189 |
Compare with all 510(k) review times · Search every KCT clearance
Top KCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aesculap, Inc. | 12 | 2025-05-13 |
| STERIS Corporation | 11 | 2023-08-07 |
| Summit Medical, Inc. | 8 | 2018-11-16 |
| Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 7 | 2023-04-20 |
| Intuitive Surgical, Inc. | 6 | 2019-02-01 |
153 more applicants have KCT clearances. See the full list in Caduvo.
Most recent KCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253988 | Nobel Biocare AB | LiteSet Trays | 2026-09-08 | 270 |
| K261935 | Dentsply Sirona, Inc. | Surgical and Prosthetic Trays | 2026-09-04 | 87 |
| K253187 | Mastel Surgical | SteriBest® Sterilization Tray System | 2026-06-18 | 265 |
| K260726 | Institut Straumann AG | Straumann® ProClean Cassette (041.800 ; 041.801) | 2026-06-03 | 90 |
| K252854 | Case Medical, Inc. | SteriTite Container System with MediTray Products | 2026-06-03 | 268 |
Recalls for KCT devices
38 product recalls in 19 recall events; 25 initiated in the last five years and 25 still open. Most recent: 2025-05-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 18 |
| 2023 | 3 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code KCT?
KCT is the FDA product code for sterilization wrap containers, trays, cassettes & other accessories. It is a Class II device, regulated under 21 CFR 880.6850 and reviewed by the General Hospital panel.
What device class is KCT?
Class II, regulation 21 CFR 880.6850. Typical premarket route: 510(k).
How long does a 510(k) take for product code KCT?
Across 282 cleared submissions the average was 186 days from receipt to decision (median 150).
Which companies have the most KCT clearances?
Aesculap, Inc. (12); STERIS Corporation (11); Summit Medical, Inc. (8); Jjgc Industria E Comercio DE Materiais Dentarios S.A. (7); Intuitive Surgical, Inc. (6).
Have KCT devices been recalled?
Yes: 38 product recalls across 19 recall events; the most recent began 2025-05-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KCT
- Run a recall and safety report across every KCT manufacturer
- Watch product code KCT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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