Cleared Traditional

K262084 - S.I.N. Instruments Kits

K262084 is an FDA 510(k) clearance for S.I.N. Instruments Kits, manufactured by S.I.N. Implant System Ltda. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K262084 · S.I.N. Implant System Ltda · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
122d
Days
Class 2
Risk

K262084 is an FDA 510(k) clearance for the S.I.N. Instruments Kits. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by S.I.N. Implant System Ltda (São Paulo, BR). The FDA issued a Cleared decision on October 22, 2026 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262084

510(k) Number K262084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date October 22, 2026
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 283
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K262084.
Sterilization Cassette (CASS-1)
K262042 · Alliedstar Medical Equipment Co., Ltd. · Oct 2026
LiteSet Trays
K253988 · Nobel Biocare AB · Sep 2026
Surgical and Prosthetic Trays
K261935 · Dentsply Sirona, Inc. · Sep 2026
SteriBest® Sterilization Tray System
K253187 · Mastel Surgical · Jun 2026
SteriTite Container System with MediTray Products
K252854 · Case Medical, Inc. · Jun 2026
Straumann® ProClean™ Cassette (041.800
K260726 · Institut Straumann AG · Jun 2026
K262084 · S.I.N. Instruments Kits
Download PDF FDA Summary S.I.N. Implant System…