510(k) Report

510(k) · Cleared

Cleared

Prisma CFM (Continuous Fluid Management System)

K946279510(k) TraditionalCleared Feb 10, 1997776-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

Cobe Renal Care, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Feb 10, 1997 after a 776-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 51 later devices descend from it.

Decided
Feb 10, 1997
Review
776 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
0

51 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2003: 3 descendants cleared2002: 2 descendants cleared1998: 2 descendants cleared2008: 3 descendants cleared2004: 2 descendants cleared2005: 3 descendants cleared2013: 7 descendants cleared2009: 2 descendants cleared2022: 2 descendants cleared2006: 2 descendants cleared2019: 1 descendant cleared2024: 2 descendants cleared2016: 1 descendant cleared2014: 2 descendants cleared2010: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2026: 3 descendants cleared2020: 3 descendants cleared2023: 1 descendant cleared2025: 3 descendants cleared1995200020052010201520202025
  1. This deviceK946279 Prisma CFM (Continuous Fluid Management System)Cobe Renal Care, Inc. · 1997
  2. Descendant · cites it directly · 39 of its ownK973322 Diapact CRRTB.Braun Medical, Inc. · 1998
  3. Descendant · 2 generations on · 29 of its ownK030470 Nxstage System OneNxstage Medical, Inc. · 2003
  4. Descendant · 3 generations on · 28 of its ownK041424 Nxstage System OneNxstage Medical, Inc. · 2004
  5. Descendant · 4 generations on · 27 of its ownK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
  6. Descendant · 5 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

1998: 22002: 22003: 32004: 22005: 32006: 22007: 32008: 32009: 22010: 12013: 72014: 22015: 12016: 12017: 22019: 12020: 32022: 22023: 12024: 22025: 32026: 3
1998high 7 (2013) · low 0 (1999)2026

Most influential descendants

Showing 5 of 51 · See all
  • K973322Diapact CRRTB.Braun Medical, Inc. · 1998 · cites it directly39descendants
  • K030470Nxstage System OneNxstage Medical, Inc. · 2003 · 2 generations on29descendants
  • K041424Nxstage System OneNxstage Medical, Inc. · 2004 · 3 generations on28descendants
  • K050525Nxstage System OneNxstage Medical, Inc. · 2005 · 4 generations on27descendants
  • K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 5 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K946279Prisma CFM (Continuous Fluid Management System)Cobe Renal Care, Inc.1997—
+1K973322Diapact CRRTB.Braun Medical, Inc.1998—
+2K030470Nxstage System OneNxstage Medical, Inc.2003—
+3K041424Nxstage System OneNxstage Medical, Inc.2004—
+4K050525Nxstage System OneNxstage Medical, Inc.20052
+5K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200220
200330
200420
200530
200620
200730
200830
200920
201010
201370
201420
201510
201610
201720
201910
202030
202220
202310
202420
202530
202630
FIG. 1 — Lineage of K946279, 1997–2026Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (51)

See all 51

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973322Diapact CRRTB.Braun Medical, Inc.199839
K032431Prisma M60/M100 SetsGambro, Inc.20038
K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp20028
K014152Nxstage Cartridge ExpressNxstage Medical, Inc.20027
K032356Nxstage System One with Cartridge ExpressNxstage Medical, Inc.20036
K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH20071
K080650Omni-DL SystemTransvivo, Inc.20080
K974652Blood Monitor Pump with Ultrafiltration ControllerBaxter Healthcare Corp19980

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?

  • Of its descendants, K973322 (B.Braun Medical, Inc., 1998) has gone furthest, with 39 descendants of its own.

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.

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—

More from Cobe Renal Care, Inc.

14 FDA decisions under this applicant name. See the company

  • K955497Gambro FH 22H Fiber Hemofltr/Prisma FH 22H Blood Tubing/Hemofltr SetCobe Renal Care, Inc. · 1997
  • K955592Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
  • K955487Gambro Polyflux 14, 17, & 21 HemodialyzersCobe Renal Care, Inc. · 1997
  • K954003Cobe Hemodynamic Recirculation MonitorCobe Renal Care, Inc. · 1997
  • K960474Cobe Centrysystem 600 HG HemodialyzersCobe Renal Care, Inc. · 1996

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/K946279 · printed Nov 6, 2026

Cite this page

510(k) Report. “K946279: Prisma CFM (Continuous Fluid Management System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946279

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026