Atlas FDA

KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105

FDA 510(k) clearance K021634 · decided 2003-01-09

Clearance details

K-number
K021634
Device name
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
Applicant
King Systems Corp.
Decision
Substantially Equivalent
Date received
2002-05-17
Decision date
2003-01-09
Days to decision
237 days
Clearance type
Traditional
Product code
CAE
Device class
1
Regulation number
868.5110
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Noblesville, IN, US
Third-party review
No
Expedited review
No

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GUEDEL AIRWAY (K953400)Mallinckrodt Medical1995-10-24
STB GUEDEL AIRWAY (K933760)Save-T-Breath Distributors C.C.1994-03-23
BERMAN AIRWAY (K936134)Smiths Industries Medical Systems, Inc.1994-01-28
GUEDEL AIRWAY (K922748)Oem Medical Div.1992-07-10
BERMAN INTUBATING/PHARYNGEAL AIRWAY (K913680)Chain Plastics Operations, Inc.1991-10-10
INTAVENT LARYNGEAL MASK (K904834)Intavent Intl. S.A.1991-07-26

Recalls involving this device

RecordFirmDate
KING LT-D, SIZE 3, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South Car recall (Z-1705-2011)King Systems Corp.2011-03-17
KING LTD, SIZE 4, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South Caro recall (Z-1706-2011)King Systems Corp.2011-03-17
KING LTD, SIZE 5, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South Caro recall (Z-1707-2011)King Systems Corp.2011-03-17
KING LTS-D, SIZE 3, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South Ca recall (Z-1708-2011)King Systems Corp.2011-03-17
KING LTS-D, SIZE 4, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South Ca recall (Z-1709-2011)King Systems Corp.2011-03-17
KING LTS-D, SIZE 5, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South Ca recall (Z-1710-2011)King Systems Corp.2011-03-17
CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noble recall (Z-1711-2011)King Systems Corp.2011-03-17
CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noble recall (Z-1712-2011)King Systems Corp.2011-03-17
CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noble recall (Z-1713-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT SIZ recall (Z-1714-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT SI recall (Z-1715-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTD213, Quantity: 5 PER CASE, KING LT-D, KIT SIZ recall (Z-1716-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT SIZ recall (Z-1717-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTD215, Quantity: 5 PER CASE, KING LT-D, KIT SIZ recall (Z-1718-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTSD413, Quantity: 5 PER CASE, KING LTSD, KIT SI recall (Z-1719-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT SI recall (Z-1720-2011)King Systems Corp.2011-03-17
KING SYSTEMS, A Consort Medical Company, KLTSD415, Quantity: 5 PER CASE, KING KLTSD, KIT S recall (Z-1721-2011)King Systems Corp.2011-03-17
KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011 Herriman recall (Z-0974-2011)King Systems Corp.2011-01-27
KING LT -D Size 4, 10-0003, Oropharyngeal Airway. King Systems Corporation 15011 Herriman recall (Z-0975-2011)King Systems Corp.2011-01-27
KING LT-D Size 5, 10-0004, Oropharyngeal Airway. King Systems Corporation 15011 Herriman B recall (Z-0976-2011)King Systems Corp.2011-01-27
KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011 Herrim recall (Z-0977-2011)King Systems Corp.2011-01-27
KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. King Systems Corporation 15011 Herrima recall (Z-0978-2011)King Systems Corp.2011-01-27
KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herrima recall (Z-0979-2011)King Systems Corp.2011-01-27
Cardiac ResQ Kit , Size 3, CRQ423, Oropharyngeal Airway. King Systems Corporation 15011 He recall (Z-0980-2011)King Systems Corp.2011-01-27
Cardiac ResQ Kit, Size 4, CRQ424, King Systems Corporation 15011 Herriman Boulevard, Noble recall (Z-0981-2011)King Systems Corp.2011-01-27
Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard, Noble recall (Z-0982-2011)King Systems Corp.2011-01-27
KING LT -D Laryngeal Tube, Size 2, KLTD202, King Systems Corporation 15011 Herriman Boulev recall (Z-0983-2011)King Systems Corp.2011-01-27
KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boul recall (Z-0984-2011)King Systems Corp.2011-01-27
KING LT -D Lanyngeal Tube, Size 3, KLTD203, King Systems Corporation 15011 Herriman Boulev recall (Z-0985-2011)King Systems Corp.2011-01-27
KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulev recall (Z-0986-2011)King Systems Corp.2011-01-27