Cleared Special

K081879 - SPSMEDICAL SPORVIEW PA CULTURE SET

K081879 is an FDA 510(k) clearance for SPSMEDICAL SPORVIEW PA CULTURE SET, manufactured by Spsmedical Supply Corp.. The device is a Class 2 General Hospital device with product code MRB cleared through the Special 510(k) pathway after a 28-day FDA review.

K081879 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
28d
Days
Class 2
Risk

K081879 is an FDA 510(k) clearance for the SPSMEDICAL SPORVIEW PA CULTURE SET. Classified as Indicator, Biological, Liquid Chemical Sterilization Process (product code MRB), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rush, US). The FDA issued a Cleared decision on July 30, 2008 after a review of 28 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 - K081879

510(k) Number K081879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date July 30, 2008
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MRB Device Classification - Class 2, Special Controls

Product Code MRB Indicator, Biological, Liquid Chemical 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.

K081879 · SPSMEDICAL SPORVIEW PA CULTURE SET
Download PDF FDA Summary Spsmedical Supply Cor…