Product code MHX: 510(k) clearances and predicates
Product code MHX covers Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M. FDA lists 430 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
430 clearances on file under product code MHX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 15 |
| 2023 | 8 |
| 2024 | 5 |
| 2025 | 8 |
| 2026 so far | 13 |
Recent clearances
Newest MHX clearances in the FDA index, with applicant and decision date:
- K260656, Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M, applicant GE Healthcare Finland Oy, decided 2026-09-01. FDA record
- K260343, Carescape Canvas 1000; Carescape Canvas Smart Display, applicant GE Healthcare Finland Oy, decided 2026-08-28. FDA record
- K260579, Infinity® Acute Care System (IACS) VG8.1, applicant Draeger Medical Systems, Inc., decided 2026-08-20. FDA record
- K251508, Telemetry Monitor (iT30, iT50), applicant Edan Instruments, Inc., decided 2026-08-06. FDA record
- K253277, Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P, applicant Ge Medical Systems Information Technologies, Inc., decided 2026-07-24. FDA record
- K254209, Radius VSM and Accessories, applicant Masimo Corporation, decided 2026-06-04. FDA record
- K252840, M12 Telemetry System, applicant Global Instrumentation, LLC, decided 2026-05-29. FDA record
- K260098, ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd., decided 2026-05-20. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Carescape Canvas 1000; Carescape Canvas Smart Display, Infinity® Acute Care System (IACS) VG8.1. Watch new MHX clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MHX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MHX clearances include Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M.
How many 510(k) clearances use product code MHX?
430 at the time this page was generated, from openFDA records.
How do I find a predicate device under MHX?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MHX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.