# K152068: Astral 100/150

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: May 13, 2016 after 294 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K902859 (1991). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
8 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133868: Astral Ventilator, Resmed, Ltd. (2014) Summary page 4.

## Most influential descendants
- K172875: Astral 100/150 (2018), 0 descendants of its own

## Recalls of this device
- Jun 25, 2026 · Class I · Z-2735-2026: Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

## Indications for use
The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. The iVAPS mode is intended for patients weighing more than 66lb (30kg). The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

Source page: https://510kreport.com/device/K152068
Methodology: https://510kreport.com/methodology