Cleared Traditional

K070595 - SPORVIEW STEAM SELF-CONTAINED BIOLOGICA...

K070595 is the FDA 510(k) clearance for SPORVIEW STEAM SELF-CONTAINED BIOLOGICA... by Spsmedical Supply Corp.. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K070595 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
83d
Days
Class 2
Risk

K070595 is an FDA 510(k) clearance for the SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rush, US). The FDA issued a Cleared decision on May 24, 2007 after a review of 83 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 Spsmedical Supply Corp. devices

Submission Details

510(k) Number K070595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2007
Decision Date May 24, 2007
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 115
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