Cleared Traditional

K860528 - THE KEYMED FIBERSCOPE STERILIZATION CASE

K860528 is an FDA 510(k) clearance for THE KEYMED FIBERSCOPE STERILIZATION CASE, manufactured by Keymed, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K860528 · Keymed, Inc. · General Hospital
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Jul 1986
Decision
154d
Days
Class 2
Risk

K860528 is an FDA 510(k) clearance for the THE KEYMED FIBERSCOPE STERILIZATION CASE. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Keymed, Inc. (Essex Ss2 5qh England, GB). The FDA issued a Cleared decision on July 15, 1986 after a review of 154 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.

View all Keymed, Inc. devices

FDA 510(k) Submission Details - K860528

510(k) Number K860528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1986
Decision Date July 15, 1986
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
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 239
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K860528.
BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · Maxxim Medical · Apr 1994
SHAVE PREP TRAY
K935739 · Cush Medical Products · Feb 1994
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · Medical Dynamics, Inc. · Apr 1989
MICROVASIVE SILICONE SPRAY
K854063 · Microvasive · Oct 1985
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983
DISPOSABLE INSTRUMENT TRAY PAD
K791412 · Anago, Inc. · Aug 1979