510(k) · Cleared
Recalled · 2007Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitaid, Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jun 30, 2005 as substantially equivalent to K852025 (Mallinckrodt Critical Care, 1985) after a 92-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 30, 2005
- Review
- 92 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 1 generation to K852025 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK852025 Brandt Tracheal Tube (Tentative)Mallinckrodt Critical Care · 1985
- This deviceK050803 Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed…Vitaid, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK113333 Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for AdultsKimberly-Clark Corporation · 2012
- Descendant · cites it directly · 0 of its ownK080821 Microcuff Pediatric Endotracheal TubeKimberly-Clark Corp. · 2008
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 | K852025 | Brandt Tracheal Tube (Tentative) | Mallinckrodt Critical Care | 1985 | — |
| 0 (this device) | K050803 | Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET Tubes | Vitaid, Ltd. | 2005 | — |
| +1 | K113333 | Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults | Kimberly-Clark Corporation | 2012 | — |
| +1 | K080821 | Microcuff Pediatric Endotracheal Tube | Kimberly-Clark Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K051649 | FDA’s K051649 is Vericis Cardiovascular Image and Information System, Model 4.0 Our OCR of the scanned summary read K051649, which FDA decided on Aug 2, 2005, after this device was decided (Jun 30, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. | 2005 |
| Kept off the family tree | K051967 | FDA’s K051967 is Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis Our OCR of the scanned summary read K051967, which FDA decided on Aug 9, 2005, after this device was decided (Jun 30, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. | 2005 |
| Kept off the family tree | K822982 | FDA’s K822982 is Midas 100 Hemacolor Stain #66030 Our OCR of the scanned summary read K822982, FDA’s number for Midas 100 Hemacolor Stain #66030 (Emd Chemicals, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sheridan CF”. Kept off the family tree. Summary page 1…cation Name: Tracheal Tubes with and without connectors Predicate Devices: Unomedical - Standard ET Tubes KOS 16496 Unomedical - Pediatric ET Tubes KOS 1967 Shertdan —~ K822982 - Sheridan CF Mallinekradt — K832025 - Brandt Hi-contour Device Description: The Vitaid endotracheal tubes are available in size… | 1982 |
| * | K852025 | Brandt Tracheal Tube (Tentative) Our OCR of the scanned summary read K832025, FDA’s number for Servomed Compact Monitor SMK 155-7/101 (Litton Medical Electronics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Brandt Hi-contour”. | 1985 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2007 | Not classified | Z-1144-2007 | Other | The tubes may kink during use which may impede or prevent ventilation. |
| Jun 4, 2007 | Not classified | Z-1143-2007 | Other | The tubes may kink during use which may impede or prevent ventilation. |
| Jun 19, 2006 | Not classified | Z-1263-06 | Other | Inadequate seals and/or holes in the pouch may compromise the sterility of the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K113333 (Kimberly-Clark Corporation, 2012) 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.
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 Vitaid ET Tubes are designed for oral/nasal intubation and are indicated for airway management. The Vitaid ET tubes have an ultra thin inflatable cuff.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050803: Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050803
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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