# K133868: Astral Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jun 4, 2014 after 166 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K902859 (1991). 55 ancestors in all.
10 later devices descend from it; 2 cite it directly.
11 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093416: Trilogy 200 Ventilator, Respironics, Inc. (2010) Summary page 1.
- K060647: LTV 1200 Ventilator, Pulmonetic Systems, Inc. (2006) Summary page 1.

## Most influential descendants
- K160481: Vivo 60 (2016), 7 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K152068: Astral 100/150 (2016), 1 descendant of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own

## Recalls of this device
- Jan 13, 2016 · Class II · Z-0746-2016: Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
- May 5, 2015 · Class II · Z-1750-2015: The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of i

## Indications for use
The Astral 1001150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 Ib)who require mechanical ventilation. The Astral device is Intended to be used in home, institution/hospltal and portable applications for both invasive and non-invasive ventilation.

Source page: https://510kreport.com/device/K133868
Methodology: https://510kreport.com/methodology