# K202970: Ventway Sparrow

- Pathway: 510(k) (Traditional)
- Applicant: Inovytech Medical Solutions, Ltd.
- Decided: Jan 29, 2021 after 121 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- 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: 12 generations back to K902859 (1991). 60 ancestors in all.
No later device cites it as a predicate yet.
5 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083688: Pulmonetic Systems LTV 1200 MR Conditional Ventilator, Pulmonetic Systems, Inc. (2009) Summary page 4.

## Indications for use
The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lb.), who require the following types of ventilatory support: SIMV VC PS, SIMV PC PS or CPAP. The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full non-vented ventilation face mask) ventilation presets. It may be used in hospitals, pre-hospital (transport) and field environments. Models VWSP100MR and VWSP900MR may be used in a Magnetic Resonance (MR) environment up to 3 Tesla. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.

Source page: https://510kreport.com/device/K202970
Methodology: https://510kreport.com/methodology