Cleared Special

K994314 - CASTLE SERIES 100HC STEAM STERILIZERS

K994314 is an FDA 510(k) clearance for CASTLE SERIES 100HC STEAM STERILIZERS, manufactured by Getinge/Castle, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Special 510(k) pathway after a 56-day FDA review.

K994314 · Getinge/Castle, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
56d
Days
Class 2
Risk

K994314 is an FDA 510(k) clearance for the CASTLE SERIES 100HC STEAM STERILIZERS. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Getinge/Castle, Inc. (Rochester, US). The FDA issued a Cleared decision on February 16, 2000 after a review of 56 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Getinge/Castle, Inc. devices

FDA 510(k) Submission Details - K994314

510(k) Number K994314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date February 16, 2000
Days to Decision 56 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 91
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K994314.
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · STERIS Corporation · May 2002
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
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STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation · Mar 2000
MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
K992744 · Midmark Corp. · Jan 2000
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K990189 · Midmark Corp. · Apr 1999
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · STERIS Corporation · Jan 1999