HAMILTON-MR1— 510(k) K122438

Clearance details

Applicant

Hamilton Medical AG

Product code

Code CBK

Device class

Class 2

Regulation

21 CFR 868.5895

Advisory panel

Anesthesiology

Date received

2012-08-10

Decision date

2013-11-20

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Bonaduz, CH

• 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

• 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

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 →

• Z-0666-2017 — Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.Class II·Terminated·Hamilton Medical, Inc.·20160926

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122438.