510(k) · Cleared
ClearedTelefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Nov 24, 2014 as substantially equivalent to K091761 (Teleflexmedical, Inc., 2009) after a 130-day review. Its family tree reaches back 6 generations to 1990. 2 of the 15 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Nov 24, 2014
- Review
- 130 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903730 (1990). 13 ancestors in all, the oldest K811033 (1981). 1 later device descends from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- 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 backK081086 Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size…Smiths Medical Asd, Inc. · 2008
- 1 generation backK091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion…Teleflexmedical, Inc. · 2009 · Recalled (Class I)
- This deviceK141939 Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion…Teleflexmedical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019 · cites it directly0descendants
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 | K081086 | Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and… | Smiths Medical Asd, Inc. | 2008 | — |
| −1 | K091761 | Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port | Teleflexmedical, Inc. | 2009 | Class I |
| 0 (this device) | K141939 | Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction… | Teleflexmedical, Inc. | 2014 | — |
| +1 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 1 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K091761 | Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortSummary page 5…Suction Port Manufacturer Teleflex Medical, Inc. Teleflex Medical, Inc. 510(k) Number N/A K091761 The Teleflex ISIS™ HVT™… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190274 | Endotracheal Tube | 2019 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091761Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. · 2009 · Direct predicate · ◆ on the line of descent in FIG. 115 Class I recalls
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 2 generations back · ◆ in the 1982 ancestors bar of FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 13 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K190274 (Tianjin Medis Medical Device Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
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. 2014, 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 TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141939: Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141939
Report an extraction error
Are you the manufacturer?
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