510(k) Report

FDA applicant

LifeLens Technologies, Inc.

Warminster, PA2 decisions2021–20260 recalls

FDA records 2 decisions for LifeLens Technologies, Inc. (Warminster, PA) from 2021 to 2026: 2 510(k) clearances. All are in product code DSH (Recorder, Magnetic Tape, Medical). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided LifeLens Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — LifeLens Technologies, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSHRecorder, Magnetic Tape, Medical2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203168LifeLens Wireless ECG MonitorLifeLens Technologies, Inc. · 20211cites it

What has FDA decided for it lately?

  • K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
  • K203168LifeLens Wireless ECG MonitorLifeLens Technologies, Inc. · 2021

All 2 as LifeLens Technologies, Inc. →