# K110631: Venner Tracheal Seal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Venner Medical (Singapore) Pte, Ltd.
- Decided: Jul 28, 2011 after 146 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912723 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885216: Attachable Lanz (Tentative), Mallinckroot, Inc. (1989) Summary page 2.
- K092733: PYTON, Arm Medical Devices, Inc. (2010) Summary page 2.

## Indications for use
The Venner TM Tracheal Seal Monitor (TSM) is indicated for use to monitor maintain and regulate the pressure within the PneuX P. N'. TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.

Source page: https://510kreport.com/device/K110631
Methodology: https://510kreport.com/methodology