Cleared Special

K020026 - RAVEN BACTERIAL SPORE STRIPS

K020026 is an FDA 510(k) clearance for RAVEN BACTERIAL SPORE STRIPS, manufactured by Raven Biological Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Special 510(k) pathway after a 26-day FDA review.

K020026 · Raven Biological Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
26d
Days
Class 2
Risk

K020026 is an FDA 510(k) clearance for the RAVEN BACTERIAL SPORE STRIPS. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Raven Biological Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on January 30, 2002 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 880.2800 - 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 - K020026

510(k) Number K020026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2002
Decision Date January 30, 2002
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.

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 K020026.
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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
STERRAD BI TEST PACK
K993775 · Advanced Sterilization Products · Jun 2000
K020026 · RAVEN BACTERIAL SPORE STRIPS
Download PDF FDA Summary Raven Biological Labo…