Cleared Traditional

K223672 - Instrument Case P1340904

K223672 is an FDA 510(k) clearance for Instrument Case P1340904, manufactured by Cochlear. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K223672 · Cochlear · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
104d
Days
Class 2
Risk

K223672 is an FDA 510(k) clearance for the Instrument Case P1340904. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Cochlear (Lone Tree, US). The FDA issued a Cleared decision on March 21, 2023 after a review of 104 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 Cochlear devices

FDA 510(k) Submission Details - K223672

510(k) Number K223672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2022
Decision Date March 21, 2023
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
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 171
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K223672.
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K222514 · S.I.N. ? Sistema DE Implante Nacional S.A. · Oct 2022
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