510(k) Report

FDA applicant

Lifesignals, Inc.

Milpitas, CA4 decisions2020–20260 recalls

FDA records 4 decisions for Lifesignals, Inc. (Milpitas, CA) from 2020 to 2026: 4 510(k) clearances. All are in product code DRG (Transmitters And Receivers, Physiological…). Its devices cite 6 predicates, 2 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 Lifesignals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12021: 12024: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Lifesignals, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lifesignals, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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