Cleared Traditional

K993775 - STERRAD BI TEST PACK

K993775 is an FDA 510(k) clearance for 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 Traditional 510(k) pathway after a 206-day FDA review.

K993775 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
206d
Days
Class 2
Risk

K993775 is an FDA 510(k) clearance for the 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 1, 2000 after a review of 206 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 Advanced Sterilization Products devices

FDA 510(k) Submission Details - K993775

510(k) Number K993775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1999
Decision Date June 01, 2000
Days to Decision 206 days
Submission Type Traditional
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
77d slower than avg
Panel avg: 129d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K993775.
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · Advanced Sterilization Products · Feb 2002
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
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · Advanced Sterilization Products · Jun 1999
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