510(k) · Cleared

Cleared

Cprmeter CPR Feedback Device

K122050510(k) TraditionalCleared Oct 22, 2012102-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 A/S · LIX Aid, Cardiopulmonary Resuscitation

Cleared on Oct 22, 2012 as substantially equivalent to K051134 (Philips Medical Systems, 2005) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 2005. 1 of the 8 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.

Decided: Oct 22, 2012
Review: 102 days
Class: Class II
Product code: LIX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K051134 (2005). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK051134 Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · Recalled (Class I)
This deviceK122050 Cprmeter CPR Feedback DeviceLaerdal Medical A/S · 2012
Descendant · cites it directly · 3 of its ownK151702 Reusable Full Silicone CoverLaerdal Medical AS · 2015
Descendant · 2 generations on · 2 of its ownK173886 CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018
Descendant · 3 generations on · 0 of its ownK201581 CPR BandCredo · 2021
Descendant · 3 generations on · 0 of its ownK183348 Reusable Silicone Cover CPRmeter 2Laerdal Medical AS · 2018
Descendant · cites it directly · 0 of its ownK130684 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2013 · Recalled

Class I recalls in this family

K051134 Heartstart MRX with Q-CPR Option, Models M3535A…direct predicate · 2005

Most influential descendants

Showing 5 of 5 · See all

K151702Reusable Full Silicone CoverLaerdal Medical AS · 2015 · cites it directly3descendants
K173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018 · 2 generations on2descendants
K201581CPR BandCredo · 2021 · 3 generations on0descendants
K183348Reusable Silicone Cover CPRmeter 2Laerdal Medical AS · 2018 · 3 generations on0descendants
K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051134	Heartstart MRX with Q-CPR Option, Models M3535A or M3536A	Philips Medical Systems	2005	Class I
0 (this device)	K122050	Cprmeter CPR Feedback Device	Laerdal Medical A/S	2012	—
+1	K151702	Reusable Full Silicone Cover	Laerdal Medical AS	2015	—
+2	K173886	CPRmeter 2 CPR Feedback Device	Laerdal Medical AS	2018	—
+3	K201581	CPR Band	Credo	2021	—
+3	K183348	Reusable Silicone Cover CPRmeter 2	Laerdal Medical AS	2018	—
+1	K130684	Philips Heartstart FR3 Automated External Defibrillator	Philips Medical Systems	2013	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2018	2	0
2021	1	0

FIG. 1 — Lineage of K122050, 2005–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K051134	Heartstart MRX with Q-CPR Option, Models M3535A or M3536A	Philips Medical Systems	2005	Class I
*	K071321	Pocketcpr Summary page 2 …r of the HeartStart MRx Monitor/Defibrillator with Q-CPR® Option (Philips Medical Systems), K05I 134 * PocketCPRTM CPR feedback device (Bio-Detek, Incorporated), K071321 Data Used in Determination of Substantial Equivalence Design verification and design validation testing demonstrates that the…	Bio-Detek, Inc.	2007	—

Also cleared against K051134: 5 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K151702	Reusable Full Silicone Cover	Laerdal Medical AS	2015	3
K130684	Philips Heartstart FR3 Automated External Defibrillator	Philips Medical Systems	2013	0

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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K151702 (Laerdal Medical AS, 2015) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K051134.

How does its category compare?

All LIX devices

LIX Aid, Cardiopulmonary Resuscitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LIX

1in 2021

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

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

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

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 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/K122050 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122050: Cprmeter 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/K122050

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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