510(k) · Cleared
ClearedReusable Silicone Cover CPRmeter 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laerdal Medical AS · LIX Aid, Cardiopulmonary Resuscitation
Cleared on Dec 17, 2018 as substantially equivalent to K173886 (Laerdal Medical AS, 2018) after a 14-day review. Its family tree reaches back 4 generations to 2005. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 17, 2018
- Review
- 14 days
- Class
- Class II
- Product code
- LIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051134 (2005). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK051134 Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · Recalled (Class I)
- 3 generations backK122050 Cprmeter CPR Feedback DeviceLaerdal Medical A/S · 2012
- 2 generations backK151702 Reusable Full Silicone CoverLaerdal Medical AS · 2015
- 1 generation backK173886 CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018
- This deviceK183348 Reusable Silicone Cover CPRmeter 2Laerdal Medical AS · 2018
Class I recalls in this family
- K051134 Heartstart MRX with Q-CPR Option, Models M3535A…4 generations back · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051134 | Heartstart MRX with Q-CPR Option, Models M3535A or M3536A | Philips Medical Systems | 2005 | Class I |
| −3 | K122050 | Cprmeter CPR Feedback Device | Laerdal Medical A/S | 2012 | — |
| −2 | K151702 | Reusable Full Silicone Cover | Laerdal Medical AS | 2015 | — |
| −1 | K173886 | CPRmeter 2 CPR Feedback Device | Laerdal Medical AS | 2018 | — |
| 0 (this device) | K183348 | Reusable Silicone Cover CPRmeter 2 | Laerdal Medical AS | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K173886 | CPRmeter 2 CPR Feedback DeviceSummary page 5…CPRmeter 2 with Silicone Cover CPRmeter 2 (this 510(k)) (K173886) The CPRmeter 2 CPR Feedback Device is used as a guide… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K051134Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K173886.
How does its category compare?
All LIX devicesLIX Aid, Cardiopulmonary Resuscitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 CPRmeter 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183348 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183348: Reusable Silicone Cover CPRmeter 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183348
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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