Cleared Special

K991675 - MODIFICATION OF: STERRAD BI TEST PACK

K991675 is an FDA 510(k) clearance for MODIFICATION OF: STERRAD BI TEST PACK, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code FRC cleared through the Special 510(k) pathway after a 29-day FDA review.

K991675 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
29d
Days
Class 2
Risk

K991675 is an FDA 510(k) clearance for the MODIFICATION OF: STERRAD BI TEST PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on June 15, 1999 after a review of 29 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.

View all Advanced Sterilization Products devices

FDA 510(k) Submission Details - K991675

510(k) Number K991675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date June 15, 1999
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K991675.
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
K994381 · Raven Biological Laboratories, Inc. · Mar 2001
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
K991618 · Propper Mfg. Co., Inc. · Jan 2001
STERRAD BI TEST PACK
K993775 · Advanced Sterilization Products · Jun 2000
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
K981497 · Steritec Products Mfg Co, Inc. · Oct 1998
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
K972747 · Propper Mfg. Co., Inc. · Jan 1998
PROSPORE II
K971430 · Raven Biological Laboratories, Inc. · May 1997