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FDA 510(k)

AccurECG Analysis System (v2.0)

K-Number: K252361 · 2025-12-22

ApplicantAccurkardia, Inc.
Decision Date2025-12-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AccurECG Analysis System (v2.0) is a medical device manufactured by Accurkardia, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K252361. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccurECG Analysis System (v2.0)?

AccurECG Analysis System (v2.0) is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Accurkardia, Inc.. The 510(k) number is K252361.

When was AccurECG Analysis System (v2.0) approved by the FDA?

AccurECG Analysis System (v2.0) received FDA 510(k) clearance on 2025-12-22, under approval number K252361.

What company makes AccurECG Analysis System (v2.0)?

AccurECG Analysis System (v2.0) is manufactured by Accurkardia, Inc..

What is the FDA product code for AccurECG Analysis System (v2.0)?

The FDA product code for AccurECG Analysis System (v2.0) is DPS.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Accurkardia, Inc.

K223013AccurECG Analysis System

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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