510(k) · Cleared
ClearedFresenius Art Hemoadsorption System
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 Jun 8, 2005 as substantially equivalent to K994267 (Fresenius Medical Care, 2000) and 1 other predicate after a 121-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 8, 2005
- Review
- 121 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921456 (1994). 3 ancestors in all, the oldest K895435 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −1 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| 0 (this device) | K050273 | Fresenius Art Hemoadsorption System | Fresenius Medical Care North America | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 |
|---|---|---|---|
| * | K994267 | Fresenius 2008KSummary page 1…d Cell, Diagnostic Classification Name: Automated blood cell separator C. Predicate Device Name: Fresenius 2008K Dialysate Delivery System K994267 Fresenius AS104 Cell Separator, #K895435 D. Device Description/Indications for Use: The indication for use fo… | 2000 |
| * | K895435 | Fresenius as 104 Cell SeparatorSummary page 1…e: Automated blood cell separator C. Predicate Device Name: Fresenius 2008K Dialysate Delivery System K994267 Fresenius AS104 Cell Separator, #K895435 D. Device Description/Indications for Use: The indication for use for the Fresenius ART Hemoadsorption System is as… | 1990 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 7 other devices also cite its predicate K994267.
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 Art Hemoadsorption system operates and monitors the extracorporeal blood circuit to perform plasma adsorption (when used with a commercially available plasma separator and a PROSORBA®Immunosorba adsorption column).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050273 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050273: Fresenius Art Hemoadsorption System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050273
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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