Cleared Traditional

K920930 - MDT/CASTLE 10/90 DUAL LOAD STATION

K920930 is an FDA 510(k) clearance for MDT/CASTLE 10/90 DUAL LOAD STATION, manufactured by Mdt Corp., Inc.. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 397-day FDA review.

K920930 · Mdt Corp., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
397d
Days
Class 2
Risk

K920930 is an FDA 510(k) clearance for the MDT/CASTLE 10/90 DUAL LOAD STATION. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 397 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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 - K920930

510(k) Number K920930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date March 31, 1993
Days to Decision 397 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
268d slower than avg
Panel avg: 129d · This submission: 397d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLF Device Classification - Class 2, Special Controls

Product Code FLF Sterilizer, Ethylene-oxide Gas
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
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 - FLF Sterilizer, Ethylene-oxide Gas

All 9
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K920930.
STERI-VAC GAS STERILIZER MODEL 8XL
K941748 · 3M Health Care, Ltd. · Dec 1994
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872 · American Sterilizer Co. · Feb 1994
STERRAD 100 STERILIZATION SYSTEM
K915682 · Johnson & Johnson Medical, Inc. · Oct 1993
STERI-VAC GAS STERILIZER MODEL 5XL
K902036 · 3M Company · Jul 1990
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783 · Sybron Corp. · Apr 1982
STERI-VAC #400C GAS STERILIZER
K812867 · 3M Company · Nov 1981