Cleared Traditional

K182414 - Aesculap SterilContainer(TM) S2 System

K182414 is the FDA 510(k) clearance for Aesculap SterilContainer(TM) S2 System by Aesculap, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K182414 · Aesculap, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
304d
Days
Class 2
Risk

K182414 is an FDA 510(k) clearance for the Aesculap® SterilContainer(TM) S2 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 July 5, 2019 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K182414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date July 05, 2019
Days to Decision 304 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
175d slower than avg
Panel avg: 129d · This submission: 304d
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 K182414.
MTS225 and MTS300 Multiple Tray Sterilization Systems
K190541 · Pmbs, LLC · Nov 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · Medtronic Sofamor Danek USA, Inc. · Oct 2019
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
K191475 · Nobel Biocare AB · Aug 2019
Sonopet iQ Sterilization Tray
K190667 · Paragon Medical · Jun 2019
DePuy Synthes Sterilization Container System
K181933 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · May 2019
Neodent Instruments Kits
K182865 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · May 2019