510(k) · Cleared
ClearedFresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L, C5L-T Platelet Sets (5-Day Storage)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Sep 5, 2006 as substantially equivalent to K895435 (Fresenius USA, Inc., 1990) and 1 other predicate after a 169-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Sep 5, 2006
- Review
- 169 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895435 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895435 Fresenius as 104 Cell SeparatorFresenius USA, Inc. · 1990
- This deviceK060734 Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius…Fresenius Medical Care North America · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895435 | Fresenius as 104 Cell Separator | Fresenius USA, Inc. | 1990 | — |
| 0 (this device) | K060734 | Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L… | Fresenius Medical Care North America | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 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? (2)
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 |
|---|---|---|---|
| * | K895435 | Fresenius as 104 Cell SeparatorSummary page 1…mated, Blood Cell, Therapeutic C. Predicate Device The predicate devices for the Fresenius OOM.TEC are the following: * Fresenius AS104 Blood Cell Separator - #K895435 (11/02/90) and; * Fresenius PIR Plasma Treatment Set for use in plasmapheresis - #K961706 (7/31/96). D. Device Descri… | 1990 |
| * | K961706 | P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell SeparatorSummary page 1…OOM.TEC are the following: * Fresenius AS104 Blood Cell Separator - #K895435 (11/02/90) and; * Fresenius PIR Plasma Treatment Set for use in plasmapheresis - #K961706 (7/31/96). D. Device Description/Indications for Use: The intended use for the Fresenius COM.TEC blood cell separator i… | 1996 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K895435.
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 | — |
What is it indicated for?
The COMTEC Blood Cell Separator is a blood component separator which utilizes centrifugal force as the basis of operation. The fields of application are as follows:
-plasma exchange
- plasma treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060734: Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L, C5L-T Platelet Sets (5-Day Storage).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060734
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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