Cleared Special

K130211 - AIRVIEW BOWIE DICK (FDA 510(k) Clearance)

Also includes:
TEST PACK, INDICATOR SHEETS

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130211 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
157d
Days
Class 2
Risk

K130211 is an FDA 510(k) clearance for the AIRVIEW BOWIE DICK. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rush, US). The FDA issued a Cleared decision on July 5, 2013 after a review of 157 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spsmedical Supply Corp. devices

Submission Details

510(k) Number K130211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2013
Decision Date July 05, 2013
Days to Decision 157 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 129d · This submission: 157d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOJ Indicator, Physical/chemical 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 - JOJ Indicator, Physical/chemical Sterilization Process

All 264
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