510(k) · Cleared
ClearedEleGARD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advancedcpr Solutions, LLC · FOA Board, Cardiopulmonary
Cleared on Jul 29, 2022 as substantially equivalent to K191689 (Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio, 2020) after a 29-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jul 29, 2022
- Review
- 29 days
- Class
- Class I
- Product code
- FOA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K191689 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK191689 EleGARD Patient Positioning SystemMinnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio · 2020
- This deviceK221901 EleGARDAdvancedcpr Solutions, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K191689 | EleGARD Patient Positioning System | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | 2020 | — |
| 0 (this device) | K221901 | EleGARD | Advancedcpr Solutions, LLC | 2022 | — |
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 FOA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K191689 | EleGARD Patient Positioning SystemSummary page 4…assification Name: FOA - Cardiopulmonary resuscitation board (21 CFR 880.6080) Predicate Device: K191689 – AdvancedCPR Solutions LLC Reference Device K211289 – Defibtech RMU 2000 Device Description: The EleGARD™… | 2020 |
| † | K211289 | RMU-2000 Automated Chest Compression System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All FOA devicesFOA Board, Cardiopulmonary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FOA
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FOA
Too few FOA 510(k)s in any year since 2007 to give a median.
Recalls per year · FOA
No recall names FOA since 2007.
Adverse event reports per year · FOA
No MAUDE report names FOA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EleGARDTM Patient Positioning System (EleGARD) is a cardiopulmonary board which may elevate a patient's head and thorax: including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS@ Chest Compression System or ARM XR Automated Chest Compressor; and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221901: EleGARD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221901
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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