Astral 100/150— 510(k) K172875
Substantially EquivalentResmed, Ltd.
FDA 510(k) clearance K172875 for Astral 100/150, Substantially Equivalent on 2018-04-26. Applicant: Resmed, Ltd.. Device class: 2.
Clearance details
- Applicant
- Resmed, Ltd.
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bella Vista, AU
Recent devices under product code CBK
view allMore clearances from Resmed, Ltd.
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172875
K-number listed on FDA's recall record- Z-2735-2026 — Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
- Z-0111-2024 — Astral 100 and Astral 150 ventilators
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172875.
Data sourced from openFDA. This site is unofficial and independent of the FDA.