510(k) · Cleared
Recalled · 2011King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
King Systems Corp. · CAE Airway, Oropharyngeal, Anesthesiology
Cleared on Jan 9, 2003 after a 237-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 30 times.
- Decided
- Jan 9, 2003
- Review
- 237 days
- Class
- Class I
- Product code
- CAE
- Recalls
- 30
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK021634 King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp. · 2003
- Descendant · cites it directly · 0 of its ownK033189 King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel…King Systems Corp. · 2004
- Descendant · cites it directly · 0 of its ownK033186 King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204…King Systems Corp. · 2004 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021634 | King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | King Systems Corp. | 2003 | — |
| +1 | K033189 | King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel, Models KLT… | King Systems Corp. | 2004 | — |
| +1 | K033186 | King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205 | King Systems Corp. | 2004 | 30 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2011 | Not classified | Z-1708-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1715-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1712-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1705-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1709-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1717-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1713-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1719-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1706-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1714-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1720-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1721-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1707-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1710-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1716-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1718-2011 | Process control | 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 of this product may result in… |
| Jan 14, 2011 | Not classified | Z-1711-2011 | Process control | 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 of this product may result in… |
| Dec 15, 2009 | Not classified | Z-0975-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0976-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0977-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0978-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0979-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0974-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0981-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0982-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0986-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0980-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0983-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0984-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
| Dec 15, 2009 | Not classified | Z-0985-2011 | Labeling False and Misleading | 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 exceeds cleared indications in that it… |
The 5 latest of 30 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033189 (King Systems Corp., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CAE devicesCAE Airway, Oropharyngeal, Anesthesiology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAE
1in 2014
2007high 1 (2014) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · CAE
Too few CAE 510(k)s in any year since 2007 to give a median.
Recalls per year · CAE
8in 2024
2007high 20 (2011) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CAE
59in 2025
2007high 80 (2019) · low 1 (2010)2025
MAUDE reports naming product code CAE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 1 | 5 |
| 2009 | 0 | — | 13 | 5 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 20 | 19 |
| 2012 | 0 | — | 10 | 8 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 1 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 0 | — | 0 | 75 |
| 2018 | 0 | — | 1 | 56 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 0 | — | 4 | 51 |
| 2023 | 0 | — | 2 | 52 |
| 2024 | 0 | — | 8 | 59 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021634: King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021634
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026