Astral 100/150— 510(k) K152068

Name: FDA 510(k) clearance K152068
Creator: U.S. Food and Drug Administration
Published: 2016-05-13

Substantially Equivalent

Resmed, Ltd.

FDA 510(k) clearance K152068 for Astral 100/150, Substantially Equivalent on 2016-05-13. 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: 2015-07-24
Decision date: 2016-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bella Vista, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBK

view all

K253647 — Evita (V800); Evita (V600)2026-05-07
K252663 — Inbentus Versatile2026-04-14
K251888 — VPAP Pediatric Face Mask2026-03-12
K232365 — Vivo 45 LS2025-12-19
K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more2025-09-10

More clearances from Resmed, Ltd.

view all

Adverse 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, 2020-01-01 through 2026-04-23. 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 K152068

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.Class I·Ongoing·ResMed Ltd.·20260625

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152068.

Data sourced from openFDA. This site is unofficial and independent of the FDA.