510(k) Report

510(k) · Cleared

Cleared

Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610N

K070222510(k) TraditionalCleared Apr 24, 200790-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 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Apr 24, 2007 as substantially equivalent to K003498 (Fresenius Medical Care North America, 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1994.

Decided
Apr 24, 2007
Review
90 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K924437 (1994). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestorK924437 · Hemospal Kit B22 / Multiflow 60 Kit · C.G.H. Medical, Inc. · 1994K980386 · Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0) · Gambro Healthcare · 1999 · recalledK032431 · Prisma M60/M100 Sets · Gambro, Inc. · 2003 · recalled1990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors K032431 · Prisma M60/M100 Sets · Gambro, Inc. · 2003 · recalledK980386 · Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0) · Gambro Healthcare · 1999 · recalledK924437 · Hemospal Kit B22 / Multiflow 60 Kit · C.G.H. Medical, Inc. · 19940
  1. Root · 3 generations backK924437 Hemospal Kit B22 / Multiflow 60 KitC.G.H. Medical, Inc. · 1994
  2. 2 generations backK980386 Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0)…Gambro Healthcare · 1999 · Recalled
  3. 1 generation backK032431 Prisma M60/M100 SetsGambro, Inc. · 2003 · Recalled
  4. This deviceK070222 Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610NFresenius Medical Care North America · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K924437Hemospal Kit B22 / Multiflow 60 KitC.G.H. Medical, Inc.1994—
−2K980386Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100…Gambro Healthcare19991
−1K032431Prisma M60/M100 SetsGambro, Inc.20036
0 (this device)K070222Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610NFresenius Medical Care North America2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200110
FIG. 1 — Lineage of K070222, 1994–2007Source: 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
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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
*K003498Fresenius Optiflux 200A
Summary page 2
…Hemofilter and the Gambro M100 Hemofilter, Gambro Hospal Multiflow 100: * K980386 (2/24/99) Gambro M100 * K032431 (9/15/03) Optiflux F16ONR * K003498 (1/4/01) D. Indications for Use/Intended Use: Intended for use in removing solutes or fluid in renal supportive therapie…
Fresenius Medical Care North America20012
*K980386Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22…
Summary page 2
…tially equivalent to the Fresenius Optiflux F16ONR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofilter, Gambro Hospal Multiflow 100: * K980386 (2/24/99) Gambro M100 * K032431 (9/15/03) Optiflux F16ONR * K003498 (1/4/01) D. Indications for Use/Intended Use:…
Gambro Healthcare19991
*K032431Prisma M60/M100 Sets
Summary page 2
…ptiflux F16ONR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofilter, Gambro Hospal Multiflow 100: * K980386 (2/24/99) Gambro M100 * K032431 (9/15/03) Optiflux F16ONR * K003498 (1/4/01) D. Indications for Use/Intended Use: Intended for use in removing so…
Gambro, Inc.20036

Also cleared against K003498: 1 other device →

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 13 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
  • 4 of the 6 ancestors have a recall of any class.
  • 1 other device also cites its predicate K003498.

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. 2007, 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?

Intended for use in removing solutes or fluid in renal supportive therapies in an acute setting. This filter can be used for intermittent and continuous therapies.

The RAC 100 Filter is intended for use in the following continuous veno-venous therapies:

* continuous veno-venous hemofiltration (CVVH)

* continuous veno-venous hemodialysis (CVVHD)

The RAC 100 Filter is intended for use in the following intermittent therapies, e.g. slow low efficiency dialysis (SLED) or other renal supportive therapies of less than 8 hours duration.

Indications for use as stated in the FDA summary.

Also cleared against K003498

1 other device cites the same predicate.

  • K051187Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 20051 recall

More from Fresenius Medical Care North America

42 FDA decisions under this applicant name. See the company

  • K252181AquaAFresenius Medical Care North America · 2025
  • K162488Optiflux dialyzerFresenius Medical Care North America · 20174 recalls
  • K152953Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America · 2015
  • K152367Optiflux dialyzerFresenius Medical Care North America · 20151 recall
  • K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014

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/K070222 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070222: Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070222

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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