# K253807: Valence InVent Xtend™ (CVG-4101-VXA)

- Pathway: 510(k) (Traditional)
- Applicant: Convergence Medical Sciences, Ltd.
- Decided: Aug 20, 2026 after 265 days
- Product code: MOD (Accessory To Continuous Ventilator (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902859 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051767: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (2005) Summary page 7.

## Indications for use
Valence InVent Xtend™ is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other (e.g. for unilateral chest trauma, asymmetric ARDS). Valence InVent Xtend™ is intended to be used with a ventilator in a pressure regulated mode (e.g. Pressure Control mode or equivalent). Valence InVent Xtend™ is intended for patients 10 years or older.

Source page: https://510kreport.com/device/K253807
Methodology: https://510kreport.com/methodology