Cleared Traditional

K924955 - MDT/HARVEY MC-8 AND MC-10

K924955 is an FDA 510(k) clearance for MDT/HARVEY MC-8 AND MC-10, manufactured by Mdt Corp., Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K924955 · Mdt Corp., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
380d
Days
Class 2
Risk

K924955 is an FDA 510(k) clearance for the MDT/HARVEY MC-8 AND MC-10. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on October 15, 1993 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Mdt Corp., Inc. devices

FDA 510(k) Submission Details - K924955

510(k) Number K924955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date October 15, 1993
Days to Decision 380 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
251d slower than avg
Panel avg: 129d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K924955.
STERRADD STERILIZATION SYSTEM
K954142 · Advanced Sterilization Products · Jun 1997
STRYKER ENCORE STERILIZER
K962755 · Stryker Corp. · Mar 1997
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K936181 · Midmark Corp. · Nov 1994
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