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FDA 510(k)

VitalRhythm

K-Number: K242129 · 2025-04-17

ApplicantVitalconnect, Inc.
Decision Date2025-04-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalRhythm is the device name listed in this FDA 510(k) record. The listed applicant is Vitalconnect, Inc.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K242129. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalRhythm?

VitalRhythm is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Vitalconnect, Inc.. The 510(k) number is K242129.

When did VitalRhythm receive FDA 510(k) clearance?

VitalRhythm received FDA 510(k) clearance on 2025-04-17, under 510(k) number K242129.

Who is the listed applicant for VitalRhythm?

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

What is the FDA product code for VitalRhythm?

The FDA product code for VitalRhythm is DQK.

Other records listing Vitalconnect, 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.

K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20K183078VitalConnect Platform, VitalPatch BiosensorK163453VitalPatch® VitalConnect PlatformK170973VitalWatch Software User Interface

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Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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