# K914103: Lifeline (R) Personal Response System

- Pathway: 510(k) (Traditional)
- Applicant: Lifeline Systems, Inc.
- Decided: Sep 27, 1991 after 15 days
- Product code: ILQ (System, Communication, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3710
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 13, 2017 · Class II · Z-1316-2018: A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
- Jul 23, 2015 · Class II · Z-0004-2016: Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.
- Apr 22, 2015 · Class II · Z-1987-2015: Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.
- Sep 11, 2009 · Not classified · Z-0419-2010: Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.

Source page: https://510kreport.com/device/K914103
Methodology: https://510kreport.com/methodology