510(k) · Cleared
ClearedIntavent Laryngeal Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intavent Intl. S.A. · CAE Airway, Oropharyngeal, Anesthesiology
Cleared on Jul 26, 1991 after a 275-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 26, 1991
- Review
- 275 days
- Class
- Class I
- Product code
- CAE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK904834 Intavent Laryngeal MaskIntavent Intl. S.A. · 1991
- Descendant · cites it directly · 4 of its ownK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- Descendant · 2 generations on · 3 of its ownK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK182548 Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd. · 2019
Most influential descendants
Showing 5 of 5 · See all- K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014 · cites it directly4descendants
- K142103Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015 · 2 generations on3descendants
- K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017 · 3 generations on1descendant
- K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019 · 4 generations on0descendants
- K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904834 | Intavent Laryngeal Mask | Intavent Intl. S.A. | 1991 | — |
| +1 | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
| +2 | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| +3 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +4 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
| +3 | K182548 | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130304 | Lma Family of Airways | 2014 | 4 |
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?
- Of its descendants, K130304 (The Laryngeal Mask Co., Ltd., 2014) has gone furthest, with 4 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CAE
59in 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 | — |
https://510kreport.com/device/K904834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K904834: Intavent Laryngeal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904834
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026