Cleared Traditional

K910649 - MDT/CASTLE 10/90 LOAD STATION

K910649 is an FDA 510(k) clearance for MDT/CASTLE 10/90 LOAD STATION, manufactured by Mdt Biologic Co.. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K910649 · Mdt Biologic Co. · General Hospital
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Sep 1991
Decision
204d
Days
Class 2
Risk

K910649 is an FDA 510(k) clearance for the MDT/CASTLE 10/90 LOAD STATION. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Mdt Biologic Co. (Rochester, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 204 days - an extended review cycle.

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. Standard predicate reliance. 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 Biologic Co. devices

FDA 510(k) Submission Details - K910649

510(k) Number K910649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date September 06, 1991
Days to Decision 204 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
75d slower than avg
Panel avg: 129d · This submission: 204d
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 14
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K910649.
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872 · American Sterilizer Co. · Feb 1994
STERRAD 100 STERILIZATION SYSTEM
K915682 · Johnson & Johnson Medical, Inc. · Oct 1993
MDT/CASTLE 10/90 DUAL LOAD STATION
K920930 · Mdt Corp., Inc. · Mar 1993
STERI-VAC GAS STERILIZER MODEL 5XL
K902036 · 3M Company · Jul 1990
EAGLE 2000 STERILIZER SERIES GAS/AERA
K832945 · Amsco Co. · Oct 1983
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783 · Sybron Corp. · Apr 1982