Cleared Traditional

K182032 - SterilContainer S System

K182032 is an FDA 510(k) clearance for SterilContainer S System, manufactured by Aesculap, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K182032 · Aesculap, Inc. · General Hospital
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Dec 2018
Decision
144d
Days
Class 2
Risk

K182032 is an FDA 510(k) clearance for the SterilContainer S System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 144 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.

View all Aesculap, Inc. devices

FDA 510(k) Submission Details - K182032

510(k) Number K182032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2018
Decision Date December 21, 2018
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
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 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K182032.
Omni Instrument Tray
K182052 · Hologic, Inc. · Feb 2019
Endoscope Sterilization Tray
K183139 · Intuitive Surgical, Inc. · Feb 2019
PRO-LITE Sterilization Tray
K183301 · STERIS Corporation · Jan 2019
InstruSafe(R) Sterilization Container
K180528 · Summit Medical, Inc. · Nov 2018
KLOCKNER SURGICAL BOX
K173642 · SOADCO, S.L. · Oct 2018
Endoscope Sterilization Tray
K180964 · Intuitive Surgical, Inc. · Sep 2018