510(k) · Cleared
ClearedTiger Endotracheal Tubes (Various Models and Sizes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tiger Medical Products, Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Mar 18, 2005 as substantially equivalent to K892432 (The Kendal Co., 1989) and 4 other predicates after a 305-day review. Its family tree reaches back 1 generation to 1989. 4 of the 8 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Mar 18, 2005
- Review
- 305 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K892432 (1989). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly. 4 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK892432 Kendall Curity Endotracheal TubesThe Kendal Co. · 1989
- This deviceK041311 Tiger Endotracheal Tubes (Various Models and Sizes)Tiger Medical Products, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
Class I recalls in this family
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eyedirect predicate · 1993
- K931164 Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EYdirect predicate · 1993
- K931165 Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur Eyedirect predicate · 1993
- K931166 Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYdirect predicate · 1993
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 |
|---|---|---|---|---|---|
| −1 | K892432 | Kendall Curity Endotracheal Tubes | The Kendal Co. | 1989 | — |
| 0 (this device) | K041311 | Tiger Endotracheal Tubes (Various Models and Sizes) | Tiger Medical Products, Ltd. | 2005 | — |
| +1 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +2 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 4 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
4 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? (5)
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 |
|---|---|---|---|
| * | K892432 | Kendall Curity Endotracheal TubesSummary page 1…bes 14-Device Classification Name: Tracheal tubes 15-Substantial Equivalency is claimed against the following device: * For oral/nasal, cuffed and uncuffed: K892432 * For nasal only, cuffed: K931164 * For oral only, cuffed: K931163 * For nasal only, uncuffed: K931165 * For… | 1989 |
| * | K931164 | Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EYSummary page 1…Tracheal tubes 15-Substantial Equivalency is claimed against the following device: * For oral/nasal, cuffed and uncuffed: K892432 * For nasal only, cuffed: K931164 * For oral only, cuffed: K931163 * For nasal only, uncuffed: K931165 * For oral only, uncuffed: K931166 11-Descri… | 1993 |
| * | K931163 | Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeSummary page 1…valency is claimed against the following device: * For oral/nasal, cuffed and uncuffed: K892432 * For nasal only, cuffed: K931164 * For oral only, cuffed: K931163 * For nasal only, uncuffed: K931165 * For oral only, uncuffed: K931166 11-Description of the Device: Tiger Medical Pro… | 1993 |
| * | K931165 | Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur EyeSummary page 1…device: * For oral/nasal, cuffed and uncuffed: K892432 * For nasal only, cuffed: K931164 * For oral only, cuffed: K931163 * For nasal only, uncuffed: K931165 * For oral only, uncuffed: K931166 11-Description of the Device: Tiger Medical Products Ltd's Endotracheal tube is availabl… | 1993 |
| * | K931166 | Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYSummary page 1…d uncuffed: K892432 * For nasal only, cuffed: K931164 * For oral only, cuffed: K931163 * For nasal only, uncuffed: K931165 * For oral only, uncuffed: K931166 11-Description of the Device: Tiger Medical Products Ltd's Endotracheal tube is available in 90 different variants distributed a… | 1993 |
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 |
|---|---|---|---|
| K160694 | Disposable Endotracheal tube, sterile, AccuCuff | 2017 | 1 |
Has anything in its family been recalled? (4 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.
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
- K931164Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EYRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 110 Class I recalls
- K931165Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur EyeRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 17 Class I recalls
- K931166Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EYRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 19 Class I recalls
What does this lineage say?
- 4 of the 5 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K160694 (Tianjin Medis Medical Device Co., Ltd., 2017) has gone furthest, with 1 descendant 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.
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 indication for use for all the product variants is grouped into three different sections: (a) Uncuffed, oral/nasal and Cuffed, oral/nasal: The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management. (b) Uncuffed, nasal only and Cuffed, nasal only: The intended use of this device is to be intubated into a patient's trachea via the nose for airway management, specifically for use in surgical…
Read the full statement (123 words)
The indication for use for all the product variants is grouped into three different sections:
(a) Uncuffed, oral/nasal and Cuffed, oral/nasal:
The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management.
(b) Uncuffed, nasal only and Cuffed, nasal only:
The intended use of this device is to be intubated into a patient's trachea via the nose for airway management, specifically for use in surgical procedures involving the head, neck and face.
(c) Uncuffed, oral only and Cuffed, oral only:
The intended use of this device is to be intubated into a patient's trachea via the mouth for airway management, specifically for use in surgical procedures involving the head, neck and face.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041311: Tiger Endotracheal Tubes (Various Models and Sizes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041311
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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