# K021634: King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105

- Pathway: 510(k) (Traditional)
- Applicant: King Systems Corp.
- Decided: Jan 9, 2003 after 237 days
- Product code: CAE (Airway, Oropharyngeal, Anesthesiology)
- Device class: 1
- Regulation: 21 CFR 868.5110
- Recalls of this device: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033189: King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel, Models KLT 303, KLT 304 and KLT 305 (2004), 0 descendants of its own
- K033186: King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205 (2004), 0 descendants of its own

## Recalls of this device
- Jan 14, 2011 · Not classified · Z-1708-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1715-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1712-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1705-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1709-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1717-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1713-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1719-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1706-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1714-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1720-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1721-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1707-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1710-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1716-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1718-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Jan 14, 2011 · Not classified · Z-1711-2011: King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use
- Dec 15, 2009 · Not classified · Z-0975-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0976-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0977-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0978-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0979-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0974-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0981-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0982-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0986-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0980-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0983-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0984-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex
- Dec 15, 2009 · Not classified · Z-0985-2011: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway ex

## Indications for use
The KING LT oropharyngeal airway is intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents.

Source page: https://510kreport.com/device/K021634
Methodology: https://510kreport.com/methodology