Cleared Special

K983679 - STATIM 5000 CASSETTE AUTOCLAVE

K983679 is an FDA 510(k) clearance for STATIM 5000 CASSETTE AUTOCLAVE, manufactured by Scican. The device is a Class 2 General Hospital device with product code FLE cleared through the Special 510(k) pathway after a 76-day FDA review.

K983679 · Scican · General Hospital
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Jan 1999
Decision
76d
Days
Class 2
Risk

K983679 is an FDA 510(k) clearance for the STATIM 5000 CASSETTE AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican (Toronto, CA). The FDA issued a Cleared decision on January 4, 1999 after a review of 76 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 Scican devices

FDA 510(k) Submission Details - K983679

510(k) Number K983679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1998
Decision Date January 04, 1999
Days to Decision 76 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 105
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K983679.
PRIMUS STEAM STERILIZERS
K991575 · Primus Sterilizer Co., Inc. · Dec 1999
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K990189 · Midmark Corp. · Apr 1999
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · STERIS Corporation · Jan 1999
EAGLE CENTURY STEAM STERILIZER
K964332 · Amsco Intl., Inc. · Jun 1998
THE SYSTEM 2S STEAM STERILIZER
K980014 · STERIS Corporation · May 1998
PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE
K962903 · Prestige Medical Corp. · Mar 1998