510(k) · Cleared
Recalled · Class II · 2017Lifeline (R) Personal Response System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifeline Systems, Inc. · ILQ System, Communication, Powered
Cleared on Sep 27, 1991 after a 15-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 4 times.
- Decided
- Sep 27, 1991
- Review
- 15 days
- Class
- Class II
- Product code
- ILQ
- Recalls
- 4
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ILQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2017 | Class II | Z-1316-2018 | Software Manufacturing/Software Deployment | 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 | Process control | Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. |
| Apr 22, 2015 | Class II | Z-1987-2015 | Software design | Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions. |
| Sep 11, 2009 | Not classified | Z-0419-2010 | Other | Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All ILQ devicesILQ System, Communication, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · ILQ
Too few ILQ 510(k)s in any year since 2007 to give a median.
Recalls per year · ILQ
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILQ
240in 2025
MAUDE reports naming product code ILQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 1 | 14 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 2 | 5 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 0 | — | 0 | 74 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 0 | 240 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K914103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914103: Lifeline (R) Personal Response System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914103
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026