Cleared Traditional

K141854 - INSTRUMENT CASSETTE (EFCCL1-F)

K141854 is an FDA 510(k) clearance for INSTRUMENT CASSETTE (EFCCL1-F), manufactured by Osung Mnd Co., Ltd.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 477-day FDA review.

K141854 · Osung Mnd Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
477d
Days
Class 2
Risk

K141854 is an FDA 510(k) clearance for the INSTRUMENT CASSETTE (EFCCL1-F). Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Osung Mnd Co., Ltd. (Carpentersville, US). The FDA issued a Cleared decision on October 29, 2015 after a review of 477 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Osung Mnd Co., Ltd. devices

FDA 510(k) Submission Details - K141854

510(k) Number K141854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2014
Decision Date October 29, 2015
Days to Decision 477 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
348d slower than avg
Panel avg: 129d · This submission: 477d
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 177
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K141854.
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Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
SterilContainer S
K151242 · Aesculap, Inc. · Oct 2015
NuVasive Sterilization Trays
K143579 · Nu Vasive, Incorporated · Aug 2015
SterilContainer S
K143729 · Aesculap, Inc. · Aug 2015