Cleared Traditional

Steripack cases and Tray Systems (K193066) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193066 · Avalign Technologies, Inc. · General Hospital
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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

Submission Details

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.

Device Classification

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 139
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