510(k) · Cleared
Recalled · 2011P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius USA, Inc. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Jul 31, 1996 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 31, 1996
- Review
- 90 days
- Class
- Class U
- Product code
- LKN
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK961706 P1R Plasma Treatment Set for Use in Plasmapheresis with the…Fresenius USA, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK050910 Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK060734 Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius…Fresenius Medical Care North America · 2006
- Descendant · 2 generations on · 0 of its ownK053322 Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006
Most influential descendants
Showing 3 of 3 · See all- K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005 · cites it directly1descendant
- K060734Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L, C5L-T…Fresenius Medical Care North America · 2006 · cites it directly0descendants
- K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961706 | P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104… | Fresenius USA, Inc. | 1996 | — |
| +1 | K050910 | Roei Working Element and Roel Cutting Loops | Roei Medical Technologies, Ltd. | 2005 | — |
| +1 | K060734 | Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L… | Fresenius Medical Care North America | 2006 | — |
| +2 | K053322 | Modification to: Roei Working Element and Roei Cutting Loops | Roei Medical Technologies, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 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 LKN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2011 | Not classified | Z-2199-2011 | PMA | Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050910 (Roei Medical Technologies, Ltd., 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LKN devicesLKN Separator, Automated, Blood Cell And Plasma, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKN
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LKN
195in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKN
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKN
71in 2025
MAUDE reports naming product code LKN, 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 | 1 | — | 1 | 10 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 1 | — | 2 | 132 |
| 2011 | 0 | — | 3 | 481 |
| 2012 | 2 | — | 1 | 372 |
| 2013 | 2 | — | 0 | 96 |
| 2014 | 1 | — | 0 | 128 |
| 2015 | 2 | — | 0 | 306 |
| 2016 | 1 | — | 0 | 206 |
| 2017 | 0 | — | 0 | 169 |
| 2018 | 3 | 195 | 0 | 55 |
| 2019 | 2 | — | 0 | 72 |
| 2020 | 0 | — | 0 | 135 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 0 | — | 0 | 132 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 71 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K961706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961706: P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961706
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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