Cleared Special

K130211 - AIRVIEW BOWIE DICK

Also marketed or referenced as:
TEST PACK, INDICATOR SHEETS

K130211 is an FDA 510(k) clearance for AIRVIEW BOWIE DICK, manufactured by Spsmedical Supply Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Special 510(k) pathway after a 157-day FDA review.

K130211 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K130211

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 129d · This submission: 157d
Pathway characteristics
Modification to existing cleared device.

JOJ Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K130211.
STERITEC GREEN CARD PACK BOWIE-DICK TEST
K132372 · Steritec Products Mfg Co, Inc. · Nov 2013
DANA REUSABLE BI TEST PACK
K130135 · Dana Products, Inc. · Nov 2013
VERIFY PROCESS INDICATOR FOR RELIANCE EPS
K130160 · STERIS Corporation · Aug 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
K122945 · Steritec Products Mfg Co, Inc. · Apr 2013
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
K120592 · Dana Products, Inc. · Feb 2013
STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
K122555 · Steritec Products Mfg Co, Inc. · Dec 2012
K130211 · AIRVIEW BOWIE DICK
Download PDF FDA Summary Spsmedical Supply Cor…