510(k) · Cleared
ClearedRhythm of Life, Model R0901-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rapid Response Solutions, LLC · LIX Aid, Cardiopulmonary Resuscitation
Cleared on Oct 14, 2009 as substantially equivalent to K003937 (Medteq Innovations Pty, Ltd., 2001) and 2 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 14, 2009
- Review
- 69 days
- Class
- Class II
- Product code
- LIX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954692 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK954692 CPR PromptCounty Line, Ltd. · 1996
- This deviceK092408 Rhythm of Life, Model R0901-05Rapid Response Solutions, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954692 | CPR Prompt | County Line, Ltd. | 1996 | — |
| 0 (this device) | K092408 | Rhythm of Life, Model R0901-05 | Rapid Response Solutions, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LIX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LIX device
- #1 K201581 CPR Bandscore 1.9 · 4 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003937 | CPR Ezy Mask and PadSummary page 2…ID RESPONSE SOLUTIONS, LLC Page 1 of 3 510(k) Summary Rhythm of Life Legally Marketed Predicate Device: K003937 CPR Ezy-Pad by Medteq Innovations Pty LTD K071321 Pocket-CPR by Bio-Detek Incorporated K954692 CPR… | 2001 |
| * | K071321 | PocketcprSummary page 2…Page 1 of 3 510(k) Summary Rhythm of Life Legally Marketed Predicate Device: K003937 CPR Ezy-Pad by Medteq Innovations Pty LTD K071321 Pocket-CPR by Bio-Detek Incorporated K954692 CPR Prompt by County Line LTD N/A LyfeTymer De… | 2007 |
| * | K954692 | CPR PromptSummary page 2…y Rhythm of Life Legally Marketed Predicate Device: K003937 CPR Ezy-Pad by Medteq Innovations Pty LTD K071321 Pocket-CPR by Bio-Detek Incorporated K954692 CPR Prompt by County Line LTD N/A LyfeTymer Device Description: The Rhythm of Life by Rapid Response… | 1996 |
| * | — | LyfeTymer Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All LIX devicesLIX Aid, Cardiopulmonary Resuscitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LIX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LIX
Too few LIX 510(k)s in any year since 2007 to give a median.
Recalls per year · LIX
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIX
7in 2025
MAUDE reports naming product code LIX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 9 |
| 2013 | 2 | — | 0 | 50 |
| 2014 | 0 | — | 0 | 55 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 2 | — | 2 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Rhythm of Life is a visual and audio timing device assisting individuals trained in CPR to provide effective resuscitation by conforming to the guidelines promoted by the American Heart Association in the field, clinical, and hospital settings. The Rhythm of Life is also intended for use by those in an educational setting who are in the process of learning CPR.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092408: Rhythm of Life, Model R0901-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092408
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026