ASTRAL VENTILATOR— 510(k) K133868
Substantially EquivalentResmed, Ltd.
FDA 510(k) clearance K133868 for ASTRAL VENTILATOR, Substantially Equivalent on 2014-06-04. 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
- San Diego, CA, US
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 K133868
K-number listed on FDA's recall record- Z-0746-2016 — Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.
- Z-1750-2015 — Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133868.
Data sourced from openFDA. This site is unofficial and independent of the FDA.