Holter ECG and ABP system (HolterABP)
FDA 510(k) K251591 · Edan Instruments, Inc.
510(k) numberK251591
Submission
- Device name
- Holter ECG and ABP system (HolterABP)
- Applicant
- Edan Instruments, Inc.
Shenzhen, CN - Received
- May 23, 2025
- Decision date
- February 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
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| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)MHX · Traditional | 07/29/2025SE |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…IYN · Traditional | 02/20/2025SE |
| K240320 | Patient Monitor (RespArray)MHX · Traditional | 06/28/2024SE |
| K232786 | Stimulation System (PA series, PR series, S series and Q series)IPF · Traditional | 05/16/2024SE |
| K232962 | Patient Monitor (iX10, iX12, iX15)MHX · Traditional | 04/19/2024SE |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sMWI · Traditional | 03/08/2024SE |
Questions and answers
When was Holter ECG and ABP system (HolterABP) cleared by the FDA?
Holter ECG and ABP system (HolterABP) (K251591) received a 510(k) decision of Substantially Equivalent on February 9, 2026, 262 days after the submission was received.
What is the product code of K251591?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.