510(k) Report

510(k) · Cleared

Cleared

CPRmeter 2 CPR Feedback Device

K173886510(k) TraditionalCleared Mar 23, 201892-day reviewClass II21 CFR 870.5210

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Laerdal Medical AS · LIX Aid, Cardiopulmonary Resuscitation

Cleared on Mar 23, 2018 as substantially equivalent to K151702 (Laerdal Medical AS, 2015) after a 92-day review. Its family tree reaches back 3 generations to 2005. 1 of the 7 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Mar 23, 2018
Review
92 days
Class
Class II
Product code
LIX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K051134 (2005). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2021: 1 descendant cleared2018: 1 descendant clearedK051134 · Heartstart MRX with Q-CPR Option, Models M3535A or M3536A · Philips Medical Systems · 2005 · Class I recallK122050 · Cprmeter CPR Feedback Device · Laerdal Medical A/S · 2012K151702 · Reusable Full Silicone Cover · Laerdal Medical AS · 201520052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 2 descendants K151702 · Reusable Full Silicone Cover · Laerdal Medical AS · 2015K122050 · Cprmeter CPR Feedback Device · Laerdal Medical A/S · 2012K051134 · Heartstart MRX with Q-CPR Option, Models M3535A or M3536A · Philips Medical Systems · 2005 · Class I recall0
  1. Root · 3 generations backK051134 Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · Recalled (Class I)
  2. 2 generations backK122050 Cprmeter CPR Feedback DeviceLaerdal Medical A/S · 2012
  3. 1 generation backK151702 Reusable Full Silicone CoverLaerdal Medical AS · 2015
  4. This deviceK173886 CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018
  5. Descendant · cites it directly · 0 of its ownK201581 CPR BandCredo · 2021
  6. Descendant · cites it directly · 0 of its ownK183348 Reusable Silicone Cover CPRmeter 2Laerdal Medical AS · 2018

Class I recalls in this family

Most influential descendants

Showing 2 of 2 · See all
  • K201581CPR BandCredo · 2021 · cites it directly0descendants
  • K183348Reusable Silicone Cover CPRmeter 2Laerdal Medical AS · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K051134Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems2005Class I
−2K122050Cprmeter CPR Feedback DeviceLaerdal Medical A/S2012—
−1K151702Reusable Full Silicone CoverLaerdal Medical AS2015—
0 (this device)K173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS2018—
+1K201581CPR BandCredo2021—
+1K183348Reusable Silicone Cover CPRmeter 2Laerdal Medical AS2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202110
FIG. 1 — Lineage of K173886, 2005–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K201581 CPR Bandscore 1.9 · 4 generations · no Class I recall
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K151702Reusable Full Silicone Cover
Summary page 4
…e Device: The CPRmeter™ 2 CPR Feedback Device is substantially equivalent to the predicate device, the CPRmeter™ CPR Feedback Device (Laerdal Medical AS) as described in K151702, cleared on August 13, 2015. Device Description: The CPRmeter™ 2 is used as a guide in administering CPR to a suspected sudden c…
Laerdal Medical AS2015—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201581CPR BandCredo20210
K183348Reusable Silicone Cover CPRmeter 2Laerdal Medical AS20180

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 · 3 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 4 ancestors has a recall of any class; 1 has a Class I recall.
  • Of its descendants, K201581 (Credo, 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LIX devices

LIX 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

2007: 12009: 12012: 22013: 22015: 12018: 22021: 1
2007high 2 (2012) · low 0 (2008)2026

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

2018: 2
2007high 2 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LIX

7in 2025

2009: 12012: 92013: 502014: 552015: 12016: 72017: 22018: 32019: 12021: 12023: 102024: 52025: 7
2007high 55 (2014) · low 0 (2007)2025

MAUDE reports naming product code LIX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—01
20100—00
20110—00
20122—09
20132—050
20140—055
20151—01
20160—07
20170—02
20182—23
20190—01
20200—00
20211—01
20220—00
20230—010
20240—05
20250—07
20260—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.

Cite this page

510(k) Report. “K173886: CPRmeter 2 CPR Feedback Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173886

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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