Cleared Traditional

Instrument Case P1340904 (K223672) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223672 · Cochlear · General Hospital
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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

Submission Details

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.

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 139
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K223672.
NobelZygoma PureSet™ Tray
K231219 · Nobel Biocare Services AG · Jun 2023
Sweden & Martina Surgical Trays
K222640 · Sweden & Martina S.P.A. · May 2023
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K223662 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Apr 2023
Aesculap AICON Container
K214041 · Aesculap, Inc. · Dec 2022
S.I.N. Instrument Kits
K222514 · S.I.N. ? Sistema DE Implante Nacional S.A. · Oct 2022
SteriTite Container System with MediTray Parts
K221492 · Case Medical, Inc. · Oct 2022