Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Accurkardia, Inc.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Accurkardia, Inc.. The 510(k) number is K252361.

When did AccurECG Analysis System (v2.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for AccurECG Analysis System (v2.0)?

The FDA 510(k) record lists Accurkardia, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Accurkardia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223013AccurECG Analysis System

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.K243305Masimo W1Masimo Corporation

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.

↑