510(k) · Cleared
ClearedLMA Fastrach ETT SU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Apr 29, 2025 as substantially equivalent to K051993 (The Laryngeal Mask Co., Ltd., 2005) after a 250-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Apr 29, 2025
- Review
- 250 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903730 (1990). 17 ancestors in all, the oldest K811033 (1981). No later device cites it as a predicate yet.
- 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 deviceK242495 LMA Fastrach ETT SUTeleflex Medical · 2025
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) | K242495 | LMA Fastrach ETT SU | Teleflex Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 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 BTR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051993 | Lma Fastrach Ett Single UseSummary page 5…egulation Number: 21 CFR 868.5730 Classification Name: Tube, Tracheal (W/Wo Connector) Classification: II Classification Panel: Anesthesiology E. Predicate Device K051993 LMA Fastrach ETT SU F. Device Description The LMA® Fastrach™ ETT Single Use has been developed specifically for use with the LMA… | 2005 |
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?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K051993.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™.
The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach ™ ETT Single Use in place.
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/K242495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242495: LMA Fastrach ETT SU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242495
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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