Cleared Traditional

K111515 - SPSMEDICAL SPORVIEW STEAM BI

K111515 is an FDA 510(k) clearance for SPSMEDICAL SPORVIEW STEAM BI, manufactured by Spsmedical Supply Corp.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K111515 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
245d
Days
Class 2
Risk

K111515 is an FDA 510(k) clearance for the SPSMEDICAL SPORVIEW STEAM BI. 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 February 1, 2012 after a review of 245 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Spsmedical Supply Corp. devices

FDA 510(k) Submission Details - K111515

510(k) Number K111515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2011
Decision Date February 01, 2012
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K111515.
STERRAD (R) 100NX DUO CYCLE TEST PACK
K111391 · Advanced Sterilization Products · Sep 2012
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
K111375 · Advanced Sterilization Products · Sep 2012
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
K113221 · North American Science Assoc., Inc. · Apr 2012
SMART READ EZTEST STEAM
K112018 · Mesa Laboratories, Inc. · Jan 2012
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
K113302 · North American Science Assoc., Inc. · Jan 2012
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K111150 · Steritec Products Mfg Co, Inc. · Jul 2011