Holter ECG and ABP system (HolterABP)— 510(k) K251591
Substantially EquivalentEdan Instruments, Inc.
FDA 510(k) clearance K251591 for Holter ECG and ABP system (HolterABP), Substantially Equivalent on 2026-02-09. Applicant: Edan Instruments, Inc.. Device class: 2.
Summary
Edan Instruments' Holter ECG and ABP system (HolterABP) is filed under product code DQK (Computer, Diagnostic, Programmable). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Edan Instruments filed from Shenzhen, China. FDA found it substantially equivalent 262 calendar days after receipt (May 23, 2025 to February 9, 2026).
Clearance details
- Applicant
- Edan Instruments, Inc.
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DQK
view allMore clearances from Edan Instruments, Inc.
view all- K251508 — Telemetry Monitor (iT30, iT50)
- K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- 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 DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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.