Cleared Traditional

K893886 - MITEK STERILIZATION TRAY

K893886 is the FDA 510(k) clearance for MITEK STERILIZATION TRAY by Mitek Surgical Products, Inc.. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K893886 · Mitek Surgical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · 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 74
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K893886.
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · Davis & Geck, Inc. · Apr 1992
MODEL #M9 ULTRACLAVE STEAM STERILIZER
K911322 · Midmark Corp. · Aug 1991
MODEL #M8 ELECTRONIC STERILIZER
K900432 · Midmark Corp. · Jul 1990
RITTER STERILIZER
K801309 · Sybron Corp. · Jun 1980
STERILIZING CASE CAT. NO. 65199
K800080 · Edward Weck, Inc. · Jan 1980
STERILIZER, EAGLE 2000
K781684 · American Sterilizer Co. · Oct 1978