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
Waters Medical Systems, LLC · KDL Set, Perfusion, Kidney, Disposable
Cleared on Aug 16, 2013 as substantially equivalent to K972066 (Trans-Med Corp., 1997) after a 429-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Aug 16, 2013
- Review
- 429 days
- Class
- Class II
- Product code
- KDL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972066 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972066 Belzer-MPSTrans-Med Corp. · 1997
- This deviceK121736 Perf-Gen Pulsatile Perfusion SolutionWaters Medical Systems, LLC · 2013
- Descendant · cites it directly · 0 of its ownK221386 PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez · 2022
- Descendant · cites it directly · 0 of its ownK211842 Servator M SALF SolutionS.A.L.F. Spa · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972066 | Belzer-MPS | Trans-Med Corp. | 1997 | — |
| 0 (this device) | K121736 | Perf-Gen Pulsatile Perfusion Solution | Waters Medical Systems, LLC | 2013 | — |
| +1 | K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | 2022 | — |
| +1 | K211842 | Servator M SALF Solution | S.A.L.F. Spa | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K972066 | Belzer-MPSSummary page 1…Isolated kidney perfusion and transport system and accessories, Class 11 Predicate Device BELZER-MPS ", Trans-Med Corporation ([K972066) Device Description The PERF-GENO Pulsatile Perfusion Solution (PERF-GEN Solution) is a clear, sterile, non-pyrogenic, non-toxi… | 1997 |
What descends from it? (2)
2 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?
How does its category compare?
All KDL devicesKDL Set, Perfusion, Kidney, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 PER-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 as stated in the FDA summary.
https://510kreport.com/device/K121736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121736: Perf-Gen Pulsatile Perfusion Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121736
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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