# K172875: Astral 100/150

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Apr 26, 2018 after 217 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902859 (1991). 57 ancestors in all.
No later device cites it as a predicate yet.
8 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152068: Astral 100/150, Resmed, Ltd. (2016) Summary page 4.

## 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.
- Sep 13, 2023 · Class I · Z-0111-2024: If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventil

## Indications for use
The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation. The iVAPS mode with optional AutoEPAP 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/K172875
Methodology: https://510kreport.com/methodology