510(k) · Cleared
ClearedEndotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Medis Medical Device Co., Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jul 30, 2019 as substantially equivalent to K141939 (Teleflexmedical, Inc., 2014) and 1 other predicate after a 172-day review. Its family tree reaches back 9 generations to 1990. 9 of the 41 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 30, 2019
- Review
- 172 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K903730 (1990). 40 ancestors in all, the oldest K811033 (1981). No later device cites it as a predicate yet. 9 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 5 generations between
- 3 generations backK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- 2 generations backK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- 1 generation backK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- This deviceK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
Show all 9 generations
- Root · 9 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 8 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 7 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 6 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 5 generations backK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- 4 generations backK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- 3 generations backK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- 2 generations backK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- 1 generation backK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- This deviceK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
Class I recalls in this family
- K091761 Teleflex Isis HVT Tracheal Tube, Cuffed, with…2 generations back · 2009
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…3 generations back · 2000
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy3 generations back · 1996
- K961840 Rusch Oral/Nasal Tracheal Tube, Plain…3 generations back · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −8 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −7 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −6 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −5 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| −4 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| −3 | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
| −2 | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| −1 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| 0 (this device) | 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 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 4 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 2 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2005 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 1 |
| 2011 | 1 | 0 |
| 2014 | 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.
9 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? (2)
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 |
|---|---|---|---|
| * | K141939 | Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with…Summary page 5…roposed device is intended for adult, provided in sterile and single use. 5. Identification of Predicate Devices Predicate Device 1 510 (k) Number: K141939 Product Name: TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port Predicate D… | 2014 |
| * | K160694 | Disposable Endotracheal tube, sterile, AccuCuffSummary page 5…: K141939 Product Name: TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port Predicate Device 2 510 (k) Number: K160694 Product Name: Disposable Endotracheal Tube, Sterile 6. Non-Clinical Test Conclusion Non clinical tests were… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (9 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 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 115 Class I recalls
- K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 132 Class I recalls
- K961840Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphyRusch Intl. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 124 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · 3 generations back · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
- K931164Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EYRusch, Inc. · 1993 · 3 generations back · ◆ in the 1993 ancestors bar of FIG. 110 Class I recalls
- K931165Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur EyeRusch, Inc. · 1993 · 3 generations back · ◆ in the 1993 ancestors bar of FIG. 17 Class I recalls
- K931166Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYRusch, Inc. · 1993 · 3 generations back · ◆ in the 1993 ancestors bar of FIG. 19 Class I recalls
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 3 generations back · ◆ in the 1982 ancestors bar of FIG. 117 Class I recalls
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 13 of the 40 ancestors have a recall of any class; 9 have a Class I recall.
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. 2019, 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 device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190274: Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190274
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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