Product code KCT: 510(k) clearances and predicates
Product code KCT covers LiteSet Trays. FDA lists 282 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
282 clearances on file under product code KCT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 11 |
| 2023 | 10 |
| 2024 | 8 |
| 2025 | 11 |
| 2026 so far | 7 |
Recent clearances
Newest KCT clearances in the FDA index, with applicant and decision date:
- K253988, LiteSet Trays, applicant Nobel Biocare AB, decided 2026-09-08. FDA record
- K261935, Surgical and Prosthetic Trays, applicant Dentsply Sirona, Inc., decided 2026-09-04. FDA record
- K253187, SteriBest® Sterilization Tray System, applicant Mastel Surgical, decided 2026-06-18. FDA record
- K252854, SteriTite Container System with MediTray Products, applicant Case Medical, Inc., decided 2026-06-03. FDA record
- K260726, Straumann® ProClean Cassette (041.800 ; 041.801), applicant Institut Straumann AG, decided 2026-06-03. FDA record
- K253791, PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid, applicant DePuy Mitek, Inc., decided 2026-02-26. FDA record
- K251614, Stainless Steel Surgical Kits, applicant Dentsply Sirona, Inc., decided 2026-02-06. FDA record
- K251756, Sterilization Trays, applicant Paragon Implant Mfg., LLC, decided 2025-11-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Surgical and Prosthetic Trays, SteriBest® Sterilization Tray System. Watch new KCT clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code KCT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KCT clearances include LiteSet Trays.
How many 510(k) clearances use product code KCT?
282 at the time this page was generated, from openFDA records.
How do I find a predicate device under KCT?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new KCT clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.