Cleared Traditional

K854063 - MICROVASIVE SILICONE SPRAY

K854063 is an FDA 510(k) clearance for MICROVASIVE SILICONE SPRAY, manufactured by Microvasive. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K854063 · Microvasive · General Hospital
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Oct 1985
Decision
21d
Days
Class 2
Risk

K854063 is an FDA 510(k) clearance for the MICROVASIVE SILICONE SPRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Microvasive (Milford, US). The FDA issued a Cleared decision on October 25, 1985 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microvasive devices

FDA 510(k) Submission Details - K854063

510(k) Number K854063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1985
Decision Date October 25, 1985
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 234
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K854063.
SHAVE PREP TRAY
K935739 · Cush Medical Products · Feb 1994
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K891983 · Medical Dynamics, Inc. · Apr 1989
THE KEYMED FIBERSCOPE STERILIZATION CASE
K860528 · Keymed, Inc. · Jul 1986
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983
DISPOSABLE INSTRUMENT TRAY PAD
K791412 · Anago, Inc. · Aug 1979
DISPOSABLE SURGICAL INSTRUMENT TIP
K782144 · Anago, Inc. · Jan 1979