Cleared Traditional

K950566 - DECOMAT 4656

K950566 is an FDA 510(k) clearance for DECOMAT 4656, manufactured by Getinge Disinfection, Inc.. The device is a Class 2 General Hospital device with product code LDS cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K950566 · Getinge Disinfection, Inc. · General Hospital
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Oct 1995
Decision
253d
Days
Class 2
Risk

K950566 is an FDA 510(k) clearance for the DECOMAT 4656. Classified as Device, Pasteurization, Hot Water (product code LDS), Class II - Special Controls.

Submitted by Getinge Disinfection, Inc. (Toms River, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 253 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6991 - 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 Getinge Disinfection, Inc. devices

FDA 510(k) Submission Details - K950566

510(k) Number K950566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1995
Decision Date October 19, 1995
Days to Decision 253 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 129d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDS Device Classification - Class 2, Special Controls

Product Code LDS Device, Pasteurization, Hot Water
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6991
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 - LDS Device, Pasteurization, Hot Water

All 7
Devices cleared under the same product code (LDS) and FDA review panel - the closest regulatory comparables to K950566.
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