Lifeline Systems, Inc.

Framingham, MA, US

Lifeline Systems, Inc. appears in FDA device records in Framingham, MA. FDA records list 4 510(k) clearances between 1983-11-14 and 2010-12-01, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 3 recalls for this company.

510(k) clearances: 4
PMA records: 0
Recall records: 3
Registered establishments: 0

FDA records under these names

1 name

FDA records resolved to Lifeline Systems, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Lifeline Systems, Incorporatedenforcement report, recall

510(k) clearance history

FDA records hold 4 510(k) clearances for Lifeline Systems, Inc. between 1983 and 2010. The busiest year on record is 1983, with 1. The most recent is 2010, with 1.

Clearances by year, as a table

510(k) clearance decisions for Lifeline Systems, Inc., by decision year
Year	Clearances
1983	1
1984	1
1991	1
2010	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K103214	M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130	DRG	Substantially Equivalent	2010-12-01
K914103	LIFELINE(R) PERSONAL RESPONSE SYSTEM	ILQ	Substantially Equivalent	1991-09-27
K834441	BLOOD PRESSURE MONITOR BP600X	DXN	Substantially Equivalent	1984-05-21
K831638	SINGLE BED ARRHYTHMIA MONITOR AM500	DSI	Substantially Equivalent	1983-11-14

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1316-2018	HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.	A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.	Class II	2017-11-13	Terminated
Z-0004-2016	Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.	Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.	Class II	2015-07-23	Terminated
Z-1987-2015	Philips GoSafe Communicator 7000L Personal emergency response system.	Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.	Class II	2015-04-22	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain