510(k) · Cleared
ClearedP0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jan 26, 2004 as substantially equivalent to K962389 (Unomedical Sdn Bhd, 1996) and 2 other predicates after a 201-day review. Its family tree reaches back 4 generations to 1990. 12 later devices descend from it.
- Decided
- Jan 26, 2004
- Review
- 201 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K903730 (1990). 12 ancestors in all, the oldest K811033 (1981). 12 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 3 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 2 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 1 generation backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- This deviceK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- Descendant · cites it directly · 6 of its ownK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- Descendant · cites it directly · 5 of its ownK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
- Descendant · 2 generations on · 4 of its ownK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- Descendant · 3 generations on · 3 of its ownK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005 · cites it directly6descendants
- K073383Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008 · cites it directly5descendants
- K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014 · 2 generations on4descendants
- K142103Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015 · 3 generations on3descendants
- K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −3 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −2 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −1 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| 0 (this device) | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| +1 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| +1 | K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | 2008 | — |
| +2 | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
| +3 | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| +2 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K962389 | Euromedical Reinforced Endotracheal TubeSummary page 1…under * Predicate 4: Euromedical Reinforced Endotracheal Tube already marketed in the USA K9623 89 the * Predicate 5: Blue Line Adj… | 1996 |
| * | K962175 | Portex Adjustable Flange Tracheostomy TubeSummary page 1…the * Predicate 5: Blue Line Adjustable flange tracheostomy tube (AFT) already marketed in USA under K962 175 * Predicate 6. Blue Line Ultra Tracheostorny tube already marketed in the USA under K030570.… | 1997 |
| * | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube Cleared while this submission was under review Summary page 1…able flange tracheostomy tube (AFT) already marketed in USA under K962 175 * Predicate 6. Blue Line Ultra Tracheostorny tube already marketed in the USA under K030570. Section 5 - Page 1 of 3 Portex Ltd. PVC, Single Use R… | 2003 |
| * | — | Mallinckrodt Tracheal tube Cuffed/Uncuffed Named without a submission number | |
| * | — | Portex Blue Line Tracheal tube PVC Cuffed (100/199) Named without a submission number |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K051993 (The Laryngeal Mask Co., Ltd., 2005) has gone furthest, with 6 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.
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 Portex Reinforced Tracheal Tubes (cuffed and uncuffed) are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032112
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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