510(k) · Cleared
ClearedPocketcpr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corp · LIX Aid, Cardiopulmonary Resuscitation
Cleared on May 10, 2012 as substantially equivalent to K071321 (Bio-Detek, Inc., 2007) after a 240-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.
- Decided
- May 10, 2012
- Review
- 240 days
- Class
- Class II
- Product code
- LIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071321 (2007). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K123597Truecpr Coaching DevicePhysio-Control, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071321 | Pocketcpr | Bio-Detek, Inc. | 2007 | — |
| 0 (this device) | K112660 | Pocketcpr | Zoll Medical Corp | 2012 | — |
| +1 | K123597 | Truecpr Coaching Device | Physio-Control, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K071321 | PocketcprSummary page 1…ctual chest wall movement is made by a state-of-the-aft accelerometer micro-chip and microprocessor performing continuous analysis. The predicate PocketCPR (2047) in K071 321 is compliant to the AHA 2005 Guidelines while the proposed PdcketCPR (2132) inthis submission is compliant to the AHA 2010 Guide… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123597 | Truecpr Coaching Device | 2013 | 0 |
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?
How does its category compare?
All LIX devicesLIX 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
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?
To assist users in the performance of effective CPR on a patient 8 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112660: Pocketcpr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112660
Report an extraction error
Are you the manufacturer?
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