510(k) · Cleared
Recalled · Class II · 2016SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organ Recovery Systems, Inc. · KDL Set, Perfusion, Kidney, Disposable
Cleared on Mar 11, 2010 as substantially equivalent to K083453 (Preservation Solutions, Inc., 2009) and 2 other predicates after a 275-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 11, 2010
- Review
- 275 days
- Class
- Class II
- Product code
- KDL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944866 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 2 generations backK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- 1 generation backK083453 CostorsolPreservation Solutions, Inc. · 2009
- This deviceK091656 SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L…Organ Recovery Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK143054 Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K143054Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −2 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| −1 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| 0 (this device) | K091656 | SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L | Organ Recovery Systems, Inc. | 2010 | — |
| +1 | K143054 | Sherpa Pak Kidney Transport System | Paragonix Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K083453 | CostorsolSummary page 1…KDN Predicate Device(s): The subject device is equivalent to the following devices: * CoStorSol® K(083453 and K(073693 a ViaSpan® K(944866 Device Description: SPS-1TM is a clea… | 2009 |
| * | K073693 | CostorsolSummary page 1…KDN Predicate Device(s): The subject device is equivalent to the following devices: * CoStorSol® K(083453 and K(073693 a ViaSpan® K(944866 Device Description: SPS-1TM is a clear to light ye… | 2008 |
| * | K944866 | Viaspan (Belzer UW - CSS)Summary page 1…ivalent to the following devices: * CoStorSol® K(083453 and K(073693 a ViaSpan® K(944866 Device Description: SPS-1TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143054 | Sherpa Pak Kidney Transport System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2016 | Class II | Z-1111-2017 | Material/Component Contamination | Organ preservation fluid recalled due to potential for bacterial contamination. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K143054 (Paragonix Technologies, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K083453.
How does its category compare?
All KDL devicesKDL Set, Perfusion, Kidney, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
SPS_1TM is intended for the flushing and cold storage of kidney, liver, and pancreas organs at the time of organ 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/K091656 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091656: SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091656
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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