Cleared Traditional

K893886 - MITEK STERILIZATION TRAY (FDA 510(k) Clearance)

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

K893886 · Mitek Surgical Products, Inc. · General Hospital
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Aug 1989
Decision
83d
Days
Class 2
Risk

K893886 is an FDA 510(k) clearance for the MITEK STERILIZATION TRAY. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Dedham, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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 Mitek Surgical Products, Inc. devices

Submission Details

510(k) Number K893886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date August 21, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 183
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