510(k) Report

510(k) · Cleared

Cleared

Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly

K133299510(k) TraditionalCleared Jul 7, 2014255-day reviewClass II21 CFR 876.5860

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

Fresenius Medical Care, North America - Renal Ther · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Jul 7, 2014 as substantially equivalent to K121341 (Fresenius Medical Care North America, 2012) and 2 other predicates after a 255-day review. Its family tree reaches back 8 generations to 1994.

Decided
Jul 7, 2014
Review
255 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
3

Its longest line of descent runs back 8 generations to K921456 (1994). 13 ancestors in all, the oldest K873155 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2011: 1 other ancestor2002: 1 other ancestor1987: 1 other ancestor1994: 1 other ancestorK921456 · 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 · recalledK101715 · Fresenius 2008T Hemodialysis Machine Model 190573 · Fresenius Medical Care North America, Design Cente · 2010 · recalledK120017 · Fresenius 2008 Hemodiaysis Machine with Bibag System · Fresenius Medical Care North America · 2012 · recalledK121341 · Fresenius 2008T Hemodialysis Machine with Bibag System · Fresenius Medical Care North America · 2012 · recalledK124035 · 2008K@Home Hemodialysis Machine · Fresenius Medical Care North America · 20131985199019952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 1 other ancestor K124035 · 2008K@Home Hemodialysis Machine · Fresenius Medical Care North America · 2013K121341 · Fresenius 2008T Hemodialysis Machine with Bibag System · Fresenius Medical Care North America · 2012 · recalledK120017 · Fresenius 2008 Hemodiaysis Machine with Bibag System · Fresenius Medical Care North America · 2012 · recalledK101715 · Fresenius 2008T Hemodialysis Machine Model 190573 · Fresenius Medical Care North America, Design Cente · 2010 · recalledK093902 · 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 · recalled−50
  1. Root · 8 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
  2. 7 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
  3. 6 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
  4. 5 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
  5. 4 generations backK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
  6. 3 generations backK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
  7. 2 generations backK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
  8. 1 generation backK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
  9. This deviceK133299 Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand AssemblyFresenius Medical Care, North America - Renal Ther · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K921456Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc.19943
−7K994267Fresenius 2008KFresenius Medical Care20005
−6K080964Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America20094
−5K093902Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America20102
−4K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente20101
−3K120017Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America20123
−2K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America20125
−1K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America2013—
0 (this device)K133299Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand AssemblyFresenius Medical Care, North America - Renal Ther2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
200210
201110
201310
FIG. 1 — Lineage of K133299, 1994–2014Source: 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.

Planning a device in KDI? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K121341Fresenius 2008T Hemodialysis Machine with Bibag System
Summary page 2
…Traditional 51O(k) Legally Marketed Predicate Device (unmodified device) 2008 series Hemodialysis Machines: 2008T Hemodialysis Machine (K121341), 2008K@'home Hemodialysis Machine with bibag (K124035), and 2008K Hemodialysis Machine (K994267). Device Description The Acid C…
Fresenius Medical Care North America20125
*K1240352008K@Home Hemodialysis Machine
Summary page 2
…gally Marketed Predicate Device (unmodified device) 2008 series Hemodialysis Machines: 2008T Hemodialysis Machine (K121341), 2008K@'home Hemodialysis Machine with bibag (K124035), and 2008K Hemodialysis Machine (K994267). Device Description The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wan…
Fresenius Medical Care North America2013—
*K994267Fresenius 2008K
Summary page 2
…d device) 2008 series Hemodialysis Machines: 2008T Hemodialysis Machine (K121341), 2008K@'home Hemodialysis Machine with bibag (K124035), and 2008K Hemodialysis Machine (K994267). Device Description The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wands are sub-assemblies intended to be used…
Fresenius Medical Care20005

Also cleared against K121341: 2 other devices →

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 20 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
  • 9 of the 13 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K121341.

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. 2014, 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?

The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a fluid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.

Indications for use as stated in the FDA summary.

Also cleared against K121341

2 other devices cite the same predicate.

  • K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013
  • K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013

Recent decisions in KDI

The KDI category page

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026

https://510kreport.com/device/K133299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133299: Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133299

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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