# K080821: Microcuff Pediatric Endotracheal Tube

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Corp.
- Decided: Apr 22, 2008 after 29 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852025 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050803: Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET Tubes, Vitaid, Ltd. (2005) Summary page 1.

## Indications for use
The Kimberly-Clark* MICROCUFF Pediatric Endotracheal Tubes are designed for oral / nasal intubation and are indicated for airway management

Source page: https://510kreport.com/device/K080821
Methodology: https://510kreport.com/methodology