LifeLens Physiological Monitor— 510(k) K260157
Substantially EquivalentLifeLens Technologies, Inc.
FDA 510(k) clearance K260157 for LifeLens Physiological Monitor, Substantially Equivalent on 2026-07-09. Applicant: LifeLens Technologies, Inc.. Device class: 2.
Summary
LifeLens Technologies' LifeLens Physiological Monitor is filed under DSH, medical magnetic tape recorders. The device name describes a monitor, which the code name doesn't mention, and the record doesn't explain the fit.
Class II, 21 CFR 870.2800. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
LifeLens filed from Ivyland, Pennsylvania. The decision came 170 calendar days after receipt (January 20 to July 9, 2026).
Clearance details
- Applicant
- LifeLens Technologies, Inc.
- Product code
- Product code DSH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ivyland, PA, US
Recent devices under product code DSH
view allMore clearances from LifeLens Technologies, Inc.
view allAdverse events under product code DSH
product code DSH- Death
- 3
- Injury
- 652
- Total
- 655
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.