CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES— 510(k) K200494

Clearance details

Applicant

GE Healthcare

Product code

Code MHX

Device class

Class 2

Regulation

21 CFR 870.1025

Advisory panel

Cardiovascular

Date received

2020-02-28

Decision date

2020-03-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Milwaukee, WI, US

• K260656 — Carescape ONE +6 more2026-09-01
• K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display2026-08-28
• K260579 — Infinity® Acute Care System (IACS) VG8.12026-08-20
• K251508 — Telemetry Monitor (iT30, iT50)2026-08-06
• K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24

• K253639 — View2026-01-08
• K242925 — MR Contour DL2025-04-01
• K232346 — Digital Expert Access with Remote Scanning2023-10-27
• K223212 — Precision DL2023-04-27
• K221680 — Xeleris V Processing and Review System2023-03-01

Death

580

Injury

2,441

Malfunction

12,655

Other

3

Total

15,679

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-2750-2020 — CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.Class II·Terminated·GE Healthcare, LLC·20200622

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200494.