HAMILTON-MR1— 510(k) K153046

Name: FDA 510(k) clearance K153046
Creator: U.S. Food and Drug Administration
Published: 2016-09-06

Substantially Equivalent

Hamilton Medical AG

FDA 510(k) clearance K153046 for HAMILTON-MR1, Substantially Equivalent on 2016-09-06. Applicant: Hamilton Medical AG. Device class: 2.

Clearance details

Applicant: Hamilton Medical AG
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2015-10-19
Decision date: 2016-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonaduz, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBK

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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 Hamilton Medical AG

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K201306 — HAMILTON-C32021-02-05
K201658 — Hamilton-C62020-12-11
K193228 — Hamilton-G52020-05-04
K181216 — HAMILTON-T1, HAMILTON-C12019-08-02
K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC40102017-09-20

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 K153046

K-number listed on FDA's recall record

Z-2528-2023 — Hamilton-MR1, REF: 161010, Intensive Care VentilatorClass I·Ongoing·Hamilton Medical, Inc.·20230726

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153046.

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