510(k) · Cleared
Recalled · Class I · 2019Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port
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 Oct 29, 2009 as substantially equivalent to K822082 (Sheridan Catheter Corp., 1982) and 2 other predicates after a 135-day review. Its family tree reaches back 5 generations to 1990. 2 of the 15 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 15 times, including 15 Class I recalls.
- Decided
- Oct 29, 2009
- Review
- 135 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 15 (15 Class I)
- Predicates
- 3
Its longest line of descent runs back 5 generations to K903730 (1990). 12 ancestors in all, the oldest K811033 (1981). 2 later devices descend from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 4 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 3 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 2 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 1 generation backK081086 Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size…Smiths Medical Asd, Inc. · 2008
- This deviceK091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion…Teleflexmedical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK141939 Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion…Teleflexmedical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
Class I recalls in this family
- K822082 Sheridan/HVT,CF, Uncuffeddirect predicate · 1982
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −4 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −3 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −2 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −1 | K081086 | Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and… | Smiths Medical Asd, Inc. | 2008 | — |
| 0 (this device) | K091761 | Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port | Teleflexmedical, Inc. | 2009 | — |
| +1 | K141939 | Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction… | Teleflexmedical, Inc. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K822082 | Sheridan/HVT,CF, UncuffedSummary page 2…evices: Predicte~evce ~ ~uatre 1()N. ar Cerd Sheridan HVT, Cuffed, Teleflex Medical, Inc. K822082 08/10/1982 Uncuffed Tracheal Tube __________ _____ Hi-Lo Evac and E… | 1982 |
| * | K965132 | HI-LO Evac and Evac II Endotracheal TubesSummary page 2…10/1982 Uncuffed Tracheal Tube __________ _____ Hi-Lo Evac and Evac II Mallinckrodt Medical K965 132 03/20/1997 Endotracheal Tubes___________ Portex Blue Line Sacett Suction Smiths Medical ASD, K081086… | 1997 |
| * | K081086 | Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and…Summary page 2…Mallinckrodt Medical K965 132 03/20/1997 Endotracheal Tubes___________ Portex Blue Line Sacett Suction Smiths Medical ASD, K081086 08/13/2008 Above the Cuff Tracheal Tube Inc. ______ _____ I. Summary of Test… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141939 | Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with… | 2014 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2019 | Class I | Z-1956-2019 | Device Design | Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube. |
| Jan 6, 2014 | Class I | Z-0950-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0953-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0954-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0957-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0958-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0959-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0961-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0963-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0955-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0956-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0960-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0962-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0951-2014 | Other | The tracheal tube can kink during patient use. |
| Jan 6, 2014 | Class I | Z-0952-2014 | Other | The tracheal tube can kink during patient use. |
The 5 latest of 15 recalls; the web page lists all.
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.
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Direct predicate · ◆ in the 1982 ancestors bar of FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K141939 (Teleflexmedical, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K822082.
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. 2009, 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/K091761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091761: Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091761
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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