Cleared Traditional

K041386 - RAVEN PROTEST - STEAM

K041386 is an FDA 510(k) clearance for RAVEN PROTEST - STEAM, 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 76-day FDA review.

K041386 · Raven Biological Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
76d
Days
Class 2
Risk

K041386 is an FDA 510(k) clearance for the RAVEN PROTEST - STEAM. 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 August 9, 2004 after a review of 76 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 - K041386

510(k) Number K041386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2004
Decision Date August 09, 2004
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 K041386.
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K041099 · Spsmedical Supply Corp. · May 2004
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
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K041386 · RAVEN PROTEST - STEAM
Download PDF FDA Summary Raven Biological Labo…