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King Systems Corp.

FDA Regulatory Profile

Summary

Total Recalls
15 (1 Class I)
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1361-2015Class IIDouble Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 February 17, 2015
Z-0709-2014Class IIKing Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottiDecember 13, 2013
Z-0002-2014Class IIKing LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult paDecember 12, 2013
Z-2255-2013Class IIIKing LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess ofSeptember 3, 2013
Z-0419-2013Class IIKING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone KNovember 2, 2012
Z-0422-2013Class IIKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child CleNovember 2, 2012
Z-0421-2013Class IIKING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone KNovember 2, 2012
Z-0418-2013Class IIKING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone KiNovember 2, 2012
Z-0423-2013Class IIKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult CNovember 2, 2012
Z-0420-2013Class IIKING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone KNovember 2, 2012
Z-0426-2013Class IIKING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child November 2, 2012
Z-0424-2013Class IIKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult CNovember 2, 2012
Z-0425-2013Class IIKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / InfantNovember 2, 2012
Z-0427-2013Class IIKING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult November 2, 2012
Z-2272-2013Class IUniversal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a dAugust 23, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 3May 4, 2004
K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205April 14, 2004
K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105January 9, 2003
K012485MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 AOctober 9, 2001
K010040SLEEVED FILTERMarch 9, 2001
K990614HME-BOOSTERMay 23, 2000
K983817BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)March 1, 1999
K973797BREATHING CIRCUIT BACTERIAL FILTERMarch 12, 1998
K953513XENON CIRCUITNovember 3, 1995
K951093KAB SYSTEMMarch 24, 1995
K950318FLEX BLUEFebruary 13, 1995
K943402K.P.R. (KING PERSONAL RESUSCITATOR)August 19, 1994
K934441KING SYSTEMS HMEDecember 2, 1993
K922789KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUITMay 26, 1993
K880681MINI-FILTER, VIROBAC IIApril 29, 1988
K880682MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISPMarch 21, 1988
K880683KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUITMarch 9, 1988
K880680KING SYSTEMS, BREATHING BAGMarch 3, 1988