Cleared Traditional

K123234 - ERMIS STERILIZATION CONTAINER SYSTEM

K123234 is an FDA 510(k) clearance for ERMIS STERILIZATION CONTAINER SYSTEM, manufactured by Ermis Medizintechnik. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K123234 · Ermis Medizintechnik · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
263d
Days
Class 2
Risk

K123234 is an FDA 510(k) clearance for the ERMIS STERILIZATION CONTAINER SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Ermis Medizintechnik (Mühlheim An Der Donau, DE). The FDA issued a Cleared decision on July 5, 2013 after a review of 263 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.

FDA 510(k) Submission Details - K123234

510(k) Number K123234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date July 05, 2013
Days to Decision 263 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
134d slower than avg
Panel avg: 129d · This submission: 263d
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 267
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K123234.
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