510(k) · Cleared
ClearedBAROguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragonix Technologies · KDN System, Perfusion, Kidney
Cleared on Aug 15, 2023 as substantially equivalent to K192869 (Pragonix Technologies, 2020) after a 235-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Aug 15, 2023
- Review
- 235 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K192869 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK192869 SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemPragonix Technologies · 2020
- This deviceK223874 BAROguardParagonix Technologies · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport System | Pragonix Technologies | 2020 | — |
| 0 (this device) | K223874 | BAROguard | Paragonix Technologies | 2023 | — |
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 KDN? 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 KDN device
- #1 K261644 Perfadex Plusscore 12.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemSummary page 4…ted kidney perfusion and transport system and accessories Class |l 21 CFR § 876.5880 KDN Paragonix LUNGguard (previously named, SherpaPak Lung Preservation System) - K192869 The subject BAROguard device results from modifications made to the cleared LUNGguard (previously named, SherpaPak Lung Preserva… | 2020 |
| † | K211155 | Auto CPAP System | 2022 |
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.
- 2 other devices also cite its predicate K192869.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KDN
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDN
135in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDN
3in 2025
MAUDE reports naming product code KDN, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 2 | — | 0 | 9 |
| 2021 | 3 | 238 | 0 | 1 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 5 | 135 | 0 | 3 |
| 2026 | 3 | 66 | 1 | — |
What is it indicated for?
BAROguard™ is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.
The intended organ storage time for BAROguard™ is up to 8 hours.
Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
Note: Partial lungs can be transported via BAROguard™ by packaging lungs per institutional protocol and UNOS guidelines.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223874: BAROguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223874
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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