Cleared Special

K003441 - CASTLE MODEL 233HC STEAM STERILIZER

K003441 is an FDA 510(k) clearance for CASTLE MODEL 233HC STEAM STERILIZER, 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 57-day FDA review.

K003441 · Getinge/Castle, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
57d
Days
Class 2
Risk

K003441 is an FDA 510(k) clearance for the CASTLE MODEL 233HC STEAM STERILIZER. 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 January 2, 2001 after a review of 57 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.

FDA 510(k) Submission Details - K003441

510(k) Number K003441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2000
Decision Date January 02, 2001
Days to Decision 57 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
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 171
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K003441.
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · STERIS Corporation · May 2001
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
K003470 · Tuttnauer Co. , Ltd. · Feb 2001
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
K993856 · Tuttnauer U.S.A Co, Ltd. · Feb 2001
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation · Mar 2000
CASTLE SERIES 100HC STEAM STERILIZERS
K994314 · Getinge/Castle, Inc. · Feb 2000
MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
K992744 · Midmark Corp. · Jan 2000
K003441 · CASTLE MODEL 233HC STEAM STERILIZER
Download PDF FDA Summary Getinge/Castle, Inc.