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FDA 510(k)

LifeLens Physiological Monitor

K-Number: K260157 · 2026-07-09

ApplicantLifeLens Technologies, Inc.
Decision Date2026-07-09
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeLens Physiological Monitor is the device name listed in this FDA 510(k) record. The listed applicant is LifeLens Technologies, Inc.. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K260157. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeLens Physiological Monitor?

LifeLens Physiological Monitor is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is LifeLens Technologies, Inc.. The 510(k) number is K260157.

When did LifeLens Physiological Monitor receive FDA 510(k) clearance?

LifeLens Physiological Monitor received FDA 510(k) clearance on 2026-07-09, under 510(k) number K260157.

Who is the listed applicant for LifeLens Physiological Monitor?

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

What is the FDA product code for LifeLens Physiological Monitor?

The FDA product code for LifeLens Physiological Monitor is DSH.

Other records listing LifeLens Technologies, 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.

K203168LifeLens Wireless ECG Monitor

Related Devices (Code: DSH)

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.

K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.K232670HiCardi+ H100MEZOO Co., 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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