Cleared Special

K990703 - SPOROX II STERILIZING & DISINFECTING SOLUTION

K990703 is an FDA 510(k) clearance for SPOROX II STERILIZING & DISINFECTING SO..., manufactured by Reckitt Benckiser, Inc.. The device is a Class 2 General Hospital device with product code MED cleared through the Special 510(k) pathway after a 26-day FDA review.

K990703 · Reckitt Benckiser, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
26d
Days
Class 2
Risk

K990703 is an FDA 510(k) clearance for the SPOROX II STERILIZING & DISINFECTING SOLUTION. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Reckitt Benckiser, Inc. (Wayne, US). The FDA issued a Cleared decision on March 30, 1999 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 - K990703

510(k) Number K990703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1999
Decision Date March 30, 1999
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

MED Device Classification - Class 2, Special Controls

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 61
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K990703 · SPOROX II STERILIZING & DISINFECTING SOLUTION
Download PDF FDA Summary Reckitt Benckiser, In…