Telemetry Monitor (iT30, iT50)— 510(k) K251508
Substantially EquivalentEdan Instruments, Inc.
FDA 510(k) clearance K251508 for Telemetry Monitor (iT30, iT50), Substantially Equivalent on 2026-08-06. Applicant: Edan Instruments, Inc.. Device class: 2.
Summary
Edan Instruments filed a Telemetry Monitor in two listed models, iT30 and iT50, under product code MHX, physiological patient monitors with arrhythmia detection or alarms.
Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Edan filed from Shenzhen, China. The decision came 447 calendar days after FDA received it (May 16, 2025 to August 6, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Edan Instruments, Inc.
- Product code
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code MHX
view allMore clearances from Edan Instruments, Inc.
view all- K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- K251591 — Holter ECG and ABP system (HolterABP)
- K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- K241882 — Fetal & Maternal Monitor (F15A, F15A Air)
- K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.