Cleared Traditional

K971430 - PROSPORE II

K971430 is an FDA 510(k) clearance for PROSPORE II, 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 35-day FDA review.

K971430 · Raven Biological Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
35d
Days
Class 2
Risk

K971430 is an FDA 510(k) clearance for the PROSPORE II. 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 May 22, 1997 after a review of 35 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.

View all Raven Biological Laboratories, Inc. devices

FDA 510(k) Submission Details - K971430

510(k) Number K971430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1997
Decision Date May 22, 1997
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 153
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K971430.
MODIFICATION OF: STERRAD BI TEST PACK
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K972747 · Propper Mfg. Co., Inc. · Jan 1998
PROSPORE
K971432 · Raven Biological Laboratories, Inc. · May 1997
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K961721 · Steritec Products Mfg Co, Inc. · Aug 1996
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K960777 · Mdt Corp., Inc. · May 1996