# K033186: King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205

- Pathway: 510(k) (Special)
- Applicant: King Systems Corp.
- Decided: Apr 14, 2004 after 196 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
Longest line of descent: 1 generation back to K021634 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021634: King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105, King Systems Corp. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K002458: King LTT M. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## 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-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Source page: https://510kreport.com/device/K033186
Methodology: https://510kreport.com/methodology