Cleared Traditional

K193066 - Steripack cases and Tray Systems

K193066 is an FDA 510(k) clearance for Steripack cases and Tray Systems, manufactured by Avalign Technologies, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K193066 · Avalign Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
276d
Days
Class 2
Risk

K193066 is an FDA 510(k) clearance for the Steripack cases and Tray Systems. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Avalign Technologies, Inc. (Fort Wayne, US). The FDA issued a Cleared decision on August 6, 2020 after a review of 276 days - an extended review cycle.

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.

View all Avalign Technologies, Inc. devices

FDA 510(k) Submission Details - K193066

510(k) Number K193066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2019
Decision Date August 06, 2020
Days to Decision 276 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
147d slower than avg
Panel avg: 129d · This submission: 276d
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 170
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K193066.
Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
K182084 · Sweden & Martina S.P.A. · Nov 2020
OsteoMed ExtremiFix Mini & Small System Tray
K202105 · Osteomed, LLC · Oct 2020
S.I.N. Instrument Kits
K201688 · S.I.N. ? Sistema DE Implante Nacional S.A. · Oct 2020
Mini Sterilizable Tray
K200858 · Implant Direct Sybron Manufacturing, LLC · Aug 2020
Benesta Medical Sterilization Tray
K193603 · Caldera Medical, Inc. · Jul 2020
UroLift System Procedure Kit Sterilization Tray
K192781 · Neotract, Inc. · Apr 2020