510(k) Report

510(k) · Cleared

Cleared

Cobe Centrysystem 145E,160E,175E,190E Dialyzers

K864831510(k) TraditionalCleared Mar 27, 1987108-day reviewClass II21 CFR 876.5820

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

Cobe Laboratories, Inc. · FJI Dialyzer, Capillary, Hollow Fiber

Cleared on Mar 27, 1987 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Mar 27, 1987
Review
108 days
Class
Class II
Product code
FJI
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1997: 1 descendant cleared1999: 2 descendants cleared2000: 1 descendant cleared1990200020102020
  1. This deviceK864831 Cobe Centrysystem 145E,160E,175E,190E DialyzersCobe Laboratories, Inc. · 1987
  2. Descendant · cites it directly · 2 of its ownK973291 Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp. · 1997
  3. Descendant · cites it directly · 1 of its ownK982337 Cuprophan and Hemophan Hollow Fiber DialyzerHaidylena Medical Egypt · 1998
  4. Descendant · 2 generations on · 0 of its ownK991908 Idemsa Hemophan Hollow Fiber DialyzersIdemsa · 2000
  5. Descendant · 2 generations on · 0 of its ownK990159 Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp. · 1999
  6. Descendant · 2 generations on · 0 of its ownK982134 Dynamic Hollow Fiber Dialyzer DS-Series Model as-851Dynamic Technology Corp. · 1999

Most influential descendants

Showing 5 of 5 · See all
  • K973291Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp. · 1997 · cites it directly2descendants
  • K982337Cuprophan and Hemophan Hollow Fiber DialyzerHaidylena Medical Egypt · 1998 · cites it directly1descendant
  • K991908Idemsa Hemophan Hollow Fiber DialyzersIdemsa · 2000 · 2 generations on0descendants
  • K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp. · 1999 · 2 generations on0descendants
  • K982134Dynamic Hollow Fiber Dialyzer DS-Series Model as-851Dynamic Technology Corp. · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864831Cobe Centrysystem 145E,160E,175E,190E DialyzersCobe Laboratories, Inc.1987—
+1K973291Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp.1997—
+1K982337Cuprophan and Hemophan Hollow Fiber DialyzerHaidylena Medical Egypt1998—
+2K991908Idemsa Hemophan Hollow Fiber DialyzersIdemsa2000—
+2K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp.1999—
+2K982134Dynamic Hollow Fiber Dialyzer DS-Series Model as-851Dynamic Technology Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199920
200010
FIG. 1 — Lineage of K864831, 1987–2000Source: 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 FJI? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K973291Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp.19972
K982337Cuprophan and Hemophan Hollow Fiber DialyzerHaidylena Medical Egypt19981

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, K973291 (Dynamic Technology Corp., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FJI devices

FJI Dialyzer, Capillary, Hollow Fiber: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJI

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJI

Too few FJI 510(k)s in any year since 2007 to give a median.

Recalls per year · FJI

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FJI

145in 2025

2007: 172008: 112009: 32010: 322011: 472012: 2112013: 5532014: 6332015: 5612016: 5622017: 1822018: 112019: 202020: 162021: 122022: 22023: 512024: 1522025: 145
2007high 633 (2014) · low 2 (2022)2025

MAUDE reports naming product code FJI, 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
20070—017
20080—011
20090—03
20100—032
20110—047
20120—0211
20131—0553
20140—0633
20150—0561
20160—0562
20170—0182
20180—011
20191—020
20200—016
20210—012
20220—02
20230—051
20240—0152
20250—1145
20260—0—

More from Cobe Laboratories, Inc.

77 FDA decisions under this applicant name. See the company

  • K923272Cobe CMS-HF Hollow Fiber Membrane OxygenatorCobe Laboratories, Inc. · 1993
  • K900105Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 1991
  • K905793Cobe Centry 2 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K905388Cobe Centrysystem 3 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K904336New Cobe Saturation/Hematocrit MonitorCobe Laboratories, Inc. · 1990

Recent decisions in FJI

The FJI category page

  • K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC · 2019
  • K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013
  • K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H…Gambro Renal Products · 2005
  • K010366Disposable Storage CapMolded Products, Inc. · 2001
  • K011148Ultraconcentrator SystemInterpore Cross Intl. · 2001

https://510kreport.com/device/K864831 · printed Nov 6, 2026

Cite this page

510(k) Report. “K864831: Cobe Centrysystem 145E,160E,175E,190E Dialyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864831

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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