Cleared Traditional

Holter ECG and ABP system (HolterABP)

K251591 · Edan Instruments, Inc. · Cardiovascular
Feb 2026
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K251591 is an FDA 510(k) clearance for the Holter ECG and ABP system (HolterABP), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 9, 2026, 262 days after receiving the submission on May 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K251591 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2025
Decision Date February 09, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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