Cleared Traditional

K163598 - Tyvek Self-Seal Pouches with STERRAD Ch...

K163598 is the FDA 510(k) clearance for Tyvek Self-Seal Pouches with STERRAD Ch... by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K163598 · Advanced Sterilization Products · General Hospital
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Jul 2017
Decision
222d
Days
Class 2
Risk

K163598 is an FDA 510(k) clearance for the Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STE.... Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvine, US). The FDA issued a Cleared decision on July 31, 2017 after a review of 222 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.

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Submission Details

510(k) Number K163598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date July 31, 2017
Days to Decision 222 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
93d slower than avg
Panel avg: 129d · This submission: 222d
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 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K163598.
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Medtronic Transportation/Sterilization Cassettes
K163279 · Medtronic Sofamor Danek USA, Inc. · Feb 2017
Sterilization Tray
K160912 · STERIS Corporation · Oct 2016