510(k) · Cleared
ClearedLma Family of Airways
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Laryngeal Mask Co., Ltd. · CAE Airway, Oropharyngeal, Anesthesiology
Cleared on May 30, 2014 as substantially equivalent to K904834 (Intavent Intl. S.A., 1991) and 2 other predicates after a 477-day review. Its family tree reaches back 6 generations to 1990. 4 later devices descend from it.
- Decided
- May 30, 2014
- Review
- 477 days
- Class
- Class I
- Product code
- CAE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K903730 (1990). 18 ancestors in all, the oldest K811033 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 5 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 4 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 3 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 2 generations backK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- 1 generation backK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- This deviceK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK182548 Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K142103Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015 · cites it directly3descendants
- K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017 · 2 generations on1descendant
- K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019 · 3 generations on0descendants
- K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −5 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −4 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −3 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −2 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| −1 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| 0 (this device) | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
| +1 | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| +2 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +3 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
| +2 | K182548 | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
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? (4)
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 |
|---|---|---|---|
| * | K904834 | Intavent Laryngeal MaskSummary page 1…rway, oropharyngeal, anesthesiology 21 CFR 868.5110 Class I Predicate Devices: LMA ClassiCTM - K904834 LMA Supreme TM -KOO 1425 All others are Class I exempt Trade Name:… | 1991 |
| Kept off the family tree | K001425 | LMA Supreme 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 6…LMA ClassiTm - K(904834 _________ _______________________ LMA ProSeal"" - K(001425 Product CAE - airway, orophaiyngeal, CAE - airway, oropharyngeal, Classification anesthesiolog… | |
| * | K991580 | Ilm Endotracheal TubeSummary page 1…TR - tracheal tube 21 CER 868.5730 Class 2 Predicate Devices: L:MA FastrachTm ETT (reusable) - K99 1580 LMA FastrachT rm ETT Single Use - K05 1993 Modification and Changes to Predicate: To seek MR Cond… | 2000 |
| * | K051993 | Lma Fastrach Ett Single UseSummary page 1…Class 2 Predicate Devices: L:MA FastrachTm ETT (reusable) - K99 1580 LMA FastrachT rm ETT Single Use - K05 1993 Modification and Changes to Predicate: To seek MR Conditional environment of use. There have been no other modifications to any… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142103 | Cuff Pilot, Sure Seal | 2015 | 3 |
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K142103 (Teleflexmedical, Inc., 2015) has gone furthest, with 3 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. 2014, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pbarynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field. The LMA Fastrach™ Eli' (reusable) and LMA FastrachTh Efl Single Use are indicated for airway management by…
Read the full statement (122 words)
The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pbarynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
The LMA Fastrach™ Eli' (reusable) and LMA FastrachTh Efl Single Use are indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.
These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130304: Lma Family of Airways.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130304
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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