510(k) Report

510(k) · Cleared

Cleared

King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel, Models KLT 303, KLT 304 and KLT 305

K033189510(k) SpecialCleared May 4, 2004216-day reviewClass I21 CFR 868.5110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

King Systems Corp. · CAE Airway, Oropharyngeal, Anesthesiology

Cleared on May 4, 2004 as substantially equivalent to K021634 (King Systems Corp., 2003) after a 216-day review. Its family tree reaches back 1 generation to 2003.

Decided
May 4, 2004
Review
216 days
Class
Class I
Product code
CAE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K021634 (2003). No later device cites it as a predicate yet.

K021634 · King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 · King Systems Corp. · 2003 · recalled2000200220042006
K021634 · King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 · King Systems Corp. · 2003 · recalled0
  1. Root · 1 generation backK021634 King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp. · 2003 · Recalled
  2. This deviceK033189 King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel…King Systems Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K021634King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp.200330
0 (this device)K033189King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel, Models KLT…King Systems Corp.2004—
FIG. 1 — Lineage of K033189, 2003–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K021634King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
Summary page 1
…he intended device is similar in intended use, material, safety and effectiveness in similar applications to: King Systems Corporation KLT Oropharyngeal Airway (51 0(k) #K021634). The intended use and indications of the modified device, as described in its labeling, are the same as those for the unmodified…
King Systems Corp.200330

Also cleared against K021634: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

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 devices

CAE Airway, Oropharyngeal, Anesthesiology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAE

1in 2014

2014: 1
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

2008: 12009: 132011: 202012: 102018: 12022: 42023: 22024: 82026 (partial year): 3
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

2007: 42008: 52009: 52010: 12011: 192012: 82013: 422014: 312015: 142016: 692017: 752018: 562019: 802020: 302021: 622022: 512023: 522024: 592025: 59
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—04
20080—15
20090—135
20100—01
20110—2019
20120—108
20130—042
20141—031
20150—014
20160—069
20170—075
20180—156
20190—080
20200—030
20210—062
20220—451
20230—252
20240—859
20250—059
20260—3—

What is it indicated for?

The KING LTS 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.

Also cleared against K021634

1 other device cites the same predicate.

  • K033186King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205King Systems Corp. · 200430 recalls

More from King Systems Corp.

18 FDA decisions under this applicant name. See the company

  • K033186King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205King Systems Corp. · 200430 recalls
  • K021634King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp. · 200330 recalls
  • K012485MS-140 All-Round Enhanced Performance Filter; MS-141 All-Round Enhanced Performance Angled; MS-142…King Systems Corp. · 2001
  • K010040Sleeved FilterKing Systems Corp. · 2001
  • K990614Hme-BoosterKing Systems Corp. · 2000

Recent decisions in CAE

The CAE category page

  • K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
  • K033186King LT-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205King Systems Corp. · 200430 recalls
  • K021634King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp. · 200330 recalls
  • K955721Cuffed Oropharyngeal Airway (Copa)Mallinckrodt Medical · 1997
  • K960240Rusch OptosafeRusch Intl. · 1996

https://510kreport.com/device/K033189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033189: King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel, Models KLT 303, KLT 304 and KLT 305.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033189

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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