# K050803: Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Vitaid, Ltd.
- Decided: Jun 30, 2005 after 92 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K852025 (1985). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852025: Brandt Tracheal Tube (Tentative), Mallinckrodt Critical Care (1985). 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”.

## Cited in the summary but kept off the family tree
- K051649: Vericis Cardiovascular Image and Information System, Model 4.0, Camtronics Medical Systems (2005). 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.
- K051967: Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis, GE Healthcare (2005). 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.
- K822982: Midas 100 Hemacolor Stain #66030, Emd Chemicals, Inc. (1982). 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.

## Most influential descendants
- K113333: Kimberly-Clark  Kim Vent Microcuff Endotracheal Tube for Adults (2012), 0 descendants of its own
- K080821: Microcuff Pediatric Endotracheal Tube (2008), 0 descendants of its own

## Recalls of this device
- Jun 4, 2007 · Not classified · Z-1144-2007: The tubes may kink during use which may impede or prevent ventilation.
- Jun 4, 2007 · Not classified · Z-1143-2007: The tubes may kink during use which may impede or prevent ventilation.
- Jun 19, 2006 · Not classified · Z-1263-06: Inadequate seals and/or holes in the pouch may compromise the sterility of the product.

## Indications for use
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.

Source page: https://510kreport.com/device/K050803
Methodology: https://510kreport.com/methodology