510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Fresenius 2008T Hemodialysis Machine

K111639510(k) SpecialCleared Oct 21, 2011130-day reviewClass II21 CFR 876.5860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fresenius Medical Care · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Oct 21, 2011 as substantially equivalent to K093902 (Fresenius Medical Care North America, 2010) after a 130-day review. Its family tree reaches back 4 generations to 1994. 1 of the 24 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it. It has been recalled once.

Decided
Oct 21, 2011
Review
130 days
Class
Class II
Product code
KDI
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to K921456 (1994). 19 later devices descend from it, 1 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2011: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2020: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2021: 2 descendants cleared2019: 1 descendant cleared2022: 2 descendants cleared2024: 4 descendants cleared2023: 2 descendants cleared, 1 with a Class I recall12026: 1 descendant clearedK921456 · Fresenius 3008/FDS-08 Dialysate Delivery System · Fresenius USA, Inc. · 1994 · recalledK994267 · Fresenius 2008K · Fresenius Medical Care · 2000 · recalledK080964 · Fresenius Model 2008T Hemodialysis Machine · Fresenius Medical Care North America · 2009 · recalledK093902 · Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 · Fresenius Medical Care North America · 2010 · recalled1990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 4 descendants7 generations forward: 2 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants, 1 with a Class I recall110 generations forward: 1 descendant K093902 · Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 · Fresenius Medical Care North America · 2010 · recalledK080964 · Fresenius Model 2008T Hemodialysis Machine · Fresenius Medical Care North America · 2009 · recalledK994267 · Fresenius 2008K · Fresenius Medical Care · 2000 · recalledK921456 · Fresenius 3008/FDS-08 Dialysate Delivery System · Fresenius USA, Inc. · 1994 · recalled0+5+10
  1. Root · 4 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
  2. 3 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
  3. 2 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
  4. 1 generation backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
  5. This deviceK111639 Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011
  6. Descendant · cites it directly · 18 of its ownK113427 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · Recalled
  7. Descendant · 2 generations on · 17 of its ownK120505 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · Recalled
  8. Descendant · 3 generations on · 16 of its ownK140866 Tablo ConsoleHome Dialysis Plus · 2014
  9. Descendant · 4 generations on · 11 of its ownK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
  10. Descendant · 5 generations on · 10 of its ownK160881 Tablo ConsoleOutset Medical, Inc. · 2016

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12015: 12016: 12019: 12020: 22021: 22022: 22023: 22024: 42026: 1
2011high 4 (2024) · low 0 (2013)2026

Class I recalls in this family

  • K233335 Tablo® Hemodialysis System9 generations on · 2023

Most influential descendants

Showing 5 of 19 · See all
  • K113427Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · cites it directly18descendants
  • K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · 2 generations on17descendants
  • K140866Tablo ConsoleHome Dialysis Plus · 2014 · 3 generations on16descendants
  • K150880Tablo Console with Wireless CapabilityOutset Medical · 2015 · 4 generations on11descendants
  • K160881Tablo ConsoleOutset Medical, Inc. · 2016 · 5 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K921456Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc.19943
−3K994267Fresenius 2008KFresenius Medical Care20005
−2K080964Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America20094
−1K093902Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America20102
0 (this device)K111639Fresenius 2008T Hemodialysis MachineFresenius Medical Care2011—
+1K113427Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America20114
+2K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente20124
+3K140866Tablo ConsoleHome Dialysis Plus2014—
+4K150880Tablo Console with Wireless CapabilityOutset Medical2015—
+5K160881Tablo ConsoleOutset Medical, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
201510
201610
201910
202020
202120
202220
202321
202440
202610
FIG. 1 — Lineage of K111639, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has a Class I recall. 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 KDI device

  1. #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K093902Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573
Summary page 1
…fication Name: Class 11 per § 876.5860 KC. Legally Marketed Predicate Device (unmodified device) Fresenius 2008T Hemodialysis Machine (K093902). L. Device Description The Eresenius 2008T Hemodialysis Machine (K093902) is indicated for acute and chronic…
Fresenius Medical Care North America20102

Also cleared against K093902: 1 other device →

What descends from it? (19)

See all 19

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113427Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America201118

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 24, 2013Class IIZ-1693-2013Nonconforming Material/ComponentIncorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · 9 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
  • 4 of the 4 ancestors have a recall of any class.
  • Of its descendants, K113427 (Fresenius Medical Care North America, 2011) has gone furthest, with 18 descendants of its own.
  • 1 other device also cites its predicate K093902.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KDI

9in 2025

2007: 112008: 62009: 42010: 92011: 52012: 62013: 112014: 82015: 52016: 52017: 82018: 22019: 42020: 92021: 22022: 72023: 72024: 72025: 92026 (partial year): 6
2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007: 91 days median2008: 148 days median2009: 236 days median2010: 186 days median2011: 85 days median2012: 153 days median2013: 247 days median2014: 164 days median2015: 69 days median2016: 230 days median2017: 188 days median2019: 263 days median2020: 266 days median2022: 259 days median2023: 157 days median2024: 235 days median2025: 199 days median2026 (partial year): 154 days median
2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007: 42009: 32010: 12011: 42012: 12013: 22014: 32015: 52016: 42017: 12018: 12019: 62021: 22022: 172023: 8, 8 Class I2024: 4, 2 Class I2025: 22026 (partial year): 2
2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007: 9162008: 1,0422009: 5222010: 8232011: 2,2702012: 1,7652013: 2,3602014: 6,1542015: 4,1822016: 7662017: 9632018: 1,7162019: 1,5872020: 1,6332021: 1,9442022: 2,1802023: 2,6922024: 2,4412025: 2,786
2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711914916
2008614801,042
200942363522
201091861823
201158542,270
2012615311,765
20131124722,360
2014816436,154
201556954,182
201652304766
201781881963
20182—11,716
2019426361,587
2020926601,633
20212—21,944
20227259172,180
202371578 (8)2,692
202472354 (2)2,441
2025919922,786
202661542—

What is it indicated for?

Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

Indications for use as stated in the FDA summary.

Also cleared against K093902

1 other device cites the same predicate.

  • K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 20101 recall

More from Fresenius Medical Care

7 FDA decisions under this applicant name. See the company

  • K2315345008X Hemodialysis SystemFresenius Medical Care · 20241 recall
  • K141997Crit-Line IV SystemFresenius Medical Care · 2015
  • K030497Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesFresenius Medical Care · 20032 Class I recalls
  • K023162Fresenius Punctur-Guard Fistula Needle SetsFresenius Medical Care · 2003
  • K022536\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving ConnectorFresenius Medical Care · 20023 recalls

Recent decisions in KDI

The KDI category page

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https://510kreport.com/device/K111639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111639: Fresenius 2008T Hemodialysis Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111639

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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