510(k) · Cleared
ClearedLabeling Change - Viaspan (TM) (Belzer UW)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The DU Pont Co. · KDL Set, Perfusion, Kidney, Disposable
Cleared on Mar 20, 1990 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Mar 20, 1990
- Review
- 46 days
- Class
- Class II
- Product code
- KDL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK900492 Labeling Change - Viaspan (TM) (Belzer UW)The DU Pont Co. · 1990
- Descendant · cites it directly · 9 of its ownK991594 Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 1999 · Recalled
- Descendant · 2 generations on · 6 of its ownK123326 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK133432 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K991594Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 1999 · cites it directly9descendants
- K123326Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013 · 2 generations on6descendants
- K133694Sherpa Pak TransporterParagonix Technologies, Inc. · 2014 · 3 generations on3descendants
- K133432Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014 · 2 generations on3descendants
- K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900492 | Labeling Change - Viaspan (TM) (Belzer UW) | The DU Pont Co. | 1990 | — |
| +1 | K991594 | Celsior Cold Flush, Storage and Transport Solution for Hearts | Sangstat Medical Corp. | 1999 | 1 |
| +2 | K123326 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2013 | — |
| +3 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| +2 | K133432 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2014 | — |
| +3 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991594 | Celsior Cold Flush, Storage and Transport Solution for Hearts | 1999 | 9 |
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, K991594 (Sangstat Medical Corp., 1999) has gone furthest, with 9 descendants of its own.
How does its category compare?
All KDL devicesKDL Set, Perfusion, Kidney, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K900492 · printed Nov 4, 2026
Cite this page
510(k) Report. “K900492: Labeling Change - Viaspan (TM) (Belzer UW).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K900492
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026