510(k) · Cleared
ClearedTruecpr Coaching Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control, Inc. · LIX Aid, Cardiopulmonary Resuscitation
Cleared on Apr 17, 2013 as substantially equivalent to K112660 (Zoll Medical Corp, 2012) and 2 other predicates after a 147-day review. Its family tree reaches back 2 generations to 2007. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 17, 2013
- Review
- 147 days
- Class
- Class II
- Product code
- LIX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K071321 (2007). 3 ancestors in all, the oldest K051134 (2005). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK071321 PocketcprBio-Detek, Inc. · 2007
- 1 generation backK112660 PocketcprZoll Medical Corp · 2012
- This deviceK123597 Truecpr Coaching DevicePhysio-Control, Inc. · 2013
Class I recalls in this family
- K051134 Heartstart MRX with Q-CPR Option, Models M3535A…direct predicate · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071321 | Pocketcpr | Bio-Detek, Inc. | 2007 | — |
| −1 | K112660 | Pocketcpr | Zoll Medical Corp | 2012 | — |
| 0 (this device) | K123597 | Truecpr Coaching Device | Physio-Control, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 1 |
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? (3)
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 |
|---|---|---|---|
| * | K112660 | PocketcprSummary page 1…on Product Code: LIX Classification Panel: Cardiovascular Device Regulation Number: 21 CFR 870.5200 Identification of PocketCPR(K1 12660, K071321) and HeartSt art MRx with Optional Q-CPR the Legally (K<051134) Marketed Device Device class: Ill (Predicate… | 2012 |
| * | K071321 | PocketcprSummary page 1…duct Code: LIX Classification Panel: Cardiovascular Device Regulation Number: 21 CFR 870.5200 Identification of PocketCPR(K1 12660, K071321) and HeartSt art MRx with Optional Q-CPR the Legally (K<051134) Marketed Device Device class: Ill (Predicate Product… | 2007 |
| * | K051134 | Heartstart MRX with Q-CPR Option, Models M3535A or M3536ASummary page 1…Device Regulation Number: 21 CFR 870.5200 Identification of PocketCPR(K1 12660, K071321) and HeartSt art MRx with Optional Q-CPR the Legally (K<051134) Marketed Device Device class: Ill (Predicate Product Code: LIX Device)Classification Device)Regulation Number:… | 2005 |
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 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All LIX devicesLIX Aid, Cardiopulmonary Resuscitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device.
The TrueCPR device is intended for use on patients eight years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123597 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123597: Truecpr Coaching Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123597
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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