510(k) · Cleared
Recalled · 2011King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205
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 Apr 14, 2004 as substantially equivalent to K021634 (King Systems Corp., 2003) after a 196-day review. Its family tree reaches back 1 generation to 2003. It has been recalled 30 times.
- Decided
- Apr 14, 2004
- Review
- 196 days
- Class
- Class I
- Product code
- CAE
- Recalls
- 30
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021634 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK021634 King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp. · 2003 · Recalled
- This deviceK033186 King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204…King Systems Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021634 | King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | King Systems Corp. | 2003 | 30 |
| 0 (this device) | K033186 | King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205 | King Systems Corp. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021634 | King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105Summary page 1…oduction into the US market. The KING LT-D is similar in intended use, material, safety and effectiveness to: King Systems Corporation KLT Oropharyngeal Airway (510(k) #K021634). The intended use and indications of the modified device, as described in its labeling, are the same as those for the unmodified… | 2003 |
| 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…rketed predicate device: Characteristic KING LT-D KING LTT M 510(k) Number TBD (this K002458 submission) Intended Use Ventilation during anesthesi… |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K021634.
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-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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033186: King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033186
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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