FDA applicant

Lifeline Systems, Inc.

Walker, MI4 decisions1983–20104 recalls

FDA records 4 decisions for Lifeline Systems, Inc. (Walker, MI) from 1983 to 2010: 4 510(k) clearances. Most are in product codes ILQ (System, Communication, Powered) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 recalls are 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 Lifeline Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lifeline Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Lifeline”

FDA records each applicant name separately; these may or may not be the same firm.

Lifeline Software, Inc. 3 Lifeline Instruments, Inc. 2 Lifeline Medical Systems, Inc. 1 Lifeline Controls 1

Lifeline Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Lifeline”