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FDA 510(k)

SafeBeat Rx App

K-Number: K251218 · 2026-02-06

ApplicantSafeBeat Rx, Inc.
Decision Date2026-02-06
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeBeat Rx App is the device name listed in this FDA 510(k) record. The listed applicant is SafeBeat Rx, Inc.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251218. 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 SafeBeat Rx App?

SafeBeat Rx App is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is SafeBeat Rx, Inc.. The 510(k) number is K251218.

When did SafeBeat Rx App receive FDA 510(k) clearance?

SafeBeat Rx App received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251218.

Who is the listed applicant for SafeBeat Rx App?

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

What is the FDA product code for SafeBeat Rx App?

The FDA product code for SafeBeat Rx App is DQK.

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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