510(k) · Cleared
ClearedPocketcpr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Detek, Inc. · LIX Aid, Cardiopulmonary Resuscitation
Cleared on Sep 12, 2007 after a 125-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Sep 12, 2007
- Review
- 125 days
- Class
- Class II
- Product code
- LIX
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK071321 PocketcprBio-Detek, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK122050 Cprmeter CPR Feedback DeviceLaerdal Medical A/S · 2012
- Descendant · 2 generations on · 3 of its ownK151702 Reusable Full Silicone CoverLaerdal Medical AS · 2015
- Descendant · 3 generations on · 2 of its ownK173886 CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018
- Descendant · cites it directly · 1 of its ownK112660 PocketcprZoll Medical Corp · 2012
- Descendant · 4 generations on · 0 of its ownK201581 CPR BandCredo · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K122050Cprmeter CPR Feedback DeviceLaerdal Medical A/S · 2012 · cites it directly5descendants
- K151702Reusable Full Silicone CoverLaerdal Medical AS · 2015 · 2 generations on3descendants
- K173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS · 2018 · 3 generations on2descendants
- K112660PocketcprZoll Medical Corp · 2012 · cites it directly1descendant
- K201581CPR BandCredo · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071321 | Pocketcpr | Bio-Detek, Inc. | 2007 | — |
| +1 | K122050 | Cprmeter CPR Feedback Device | Laerdal Medical A/S | 2012 | — |
| +2 | K151702 | Reusable Full Silicone Cover | Laerdal Medical AS | 2015 | — |
| +3 | K173886 | CPRmeter 2 CPR Feedback Device | Laerdal Medical AS | 2018 | — |
| +1 | K112660 | Pocketcpr | Zoll Medical Corp | 2012 | — |
| +4 | K201581 | CPR Band | Credo | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | CPR Ezy Named without a submission number |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K122050 (Laerdal Medical A/S, 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LIX devicesLIX Aid, Cardiopulmonary Resuscitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 victim 8 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071321: Pocketcpr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071321
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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