Cleared Traditional

K041784 - RAVEN PROTEST - EO

K041784 is an FDA 510(k) clearance for RAVEN PROTEST - EO, manufactured by Raven Biological Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K041784 · Raven Biological Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
74d
Days
Class 2
Risk

K041784 is an FDA 510(k) clearance for the RAVEN PROTEST - EO. 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 September 13, 2004 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041784

510(k) Number K041784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2004
Decision Date September 13, 2004
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 198
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K041784.
STERRAD NX CHALLENGE PACK
K042450 · Advanced Sterilization Products · May 2005
SPOR-TEST PA BIOLOGICAL INDICATOR KIT
K050664 · Getinge USA, Inc. · Apr 2005
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
K050591 · Raven Biological Laboratories, Inc. · Mar 2005
RAVEN PROTEST - STEAM
K041386 · Raven Biological Laboratories, Inc. · Aug 2004
MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
K032914 · Raven Biological Laboratories, Inc. · May 2004
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K041099 · Spsmedical Supply Corp. · May 2004
K041784 · RAVEN PROTEST - EO
Download PDF FDA Summary Raven Biological Labo…