# K131254: Kimvent Microcuff Subglottic Suctioning Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Aug 20, 2013 after 110 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 5 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871204 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120985: Kimvent Microcuff Subglottic Suctioning, Kimberly-Clark Corp. (2012) Summary page 1.

## Recalls of this device
- Nov 17, 2014 · Class I · Z-0867-2015: The cuff inflation line may detach from the endotracheal tube during use.
- Nov 17, 2014 · Class I · Z-0865-2015: The cuff inflation line may detach from the endotracheal tube during use.
- Nov 17, 2014 · Class I · Z-0866-2015: The cuff inflation line may detach from the endotracheal tube during use.
- Nov 17, 2014 · Class I · Z-0868-2015: The cuff inflation line may detach from the endotracheal tube during use.
- Nov 17, 2014 · Class I · Z-0869-2015: The cuff inflation line may detach from the endotracheal tube during use.

## Indications for use
KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

Source page: https://510kreport.com/device/K131254
Methodology: https://510kreport.com/methodology