Cleared Special

K050664 - SPOR-TEST PA BIOLOGICAL INDICATOR KIT

K050664 is an FDA 510(k) clearance for SPOR-TEST PA BIOLOGICAL INDICATOR KIT, manufactured by Getinge USA, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Special 510(k) pathway after a 23-day FDA review.

K050664 · Getinge USA, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
23d
Days
Class 2
Risk

K050664 is an FDA 510(k) clearance for the SPOR-TEST PA BIOLOGICAL INDICATOR KIT. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Getinge USA, Inc. (Rochester, US). The FDA issued a Cleared decision on April 7, 2005 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 - K050664

510(k) Number K050664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2005
Decision Date April 07, 2005
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - FRC Indicator, Biological Sterilization Process

All 198
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K050664.
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K041386 · Raven Biological Laboratories, Inc. · Aug 2004
K050664 · SPOR-TEST PA BIOLOGICAL INDICATOR KIT
Download PDF FDA Summary Getinge USA, Inc.