510(k) · Cleared
ClearedPERF-GEN Pulsatile Perfusion Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Georges Lopez · KDL Set, Perfusion, Kidney, Disposable
Cleared on Jun 14, 2022 as substantially equivalent to K121736 (Waters Medical Systems, LLC, 2013) after a 32-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jun 14, 2022
- Review
- 32 days
- Class
- Class II
- Product code
- KDL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972066 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KDL? 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 KDL device
- #1 K241239 OrganProtex HTK Solutionscore 9.9 · 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 |
|---|---|---|---|
| * | K121736 | Perf-Gen Pulsatile Perfusion SolutionSummary page 4…Class II Product Code: KDL III. Predicate Devices Identification PERF-GEN Pulsatile Perfusion Solution – Waters Instruments, Inc. – K121736 IV. Device Description Institut Georges Lopez manufactures the PERF-GEN Pulsatile Perfusion Solution according to the soluti… | 2013 |
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K121736.
How does its category compare?
All KDL devicesKDL Set, Perfusion, Kidney, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KDL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDL
Too few KDL 510(k)s in any year since 2007 to give a median.
Recalls per year · KDL
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDL
1in 2025
MAUDE reports naming product code KDL, 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 | 7 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 30 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PERF-GEN Pulsatile Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
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/K221386 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221386: PERF-GEN Pulsatile Perfusion Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221386
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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