510(k) Report

510(k) · Cleared

Cleared

REDY 2000

K882428510(k) TraditionalCleared Oct 25, 1988134-day reviewClass II21 CFR 876.5600

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

Organon Teknika Corp. · FKT System, Dialysate Delivery, Sorbent Regenerated

Cleared on Oct 25, 1988 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Oct 25, 1988
Review
134 days
Class
Class II
Product code
FKT
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK882428 REDY 2000Organon Teknika Corp. · 1988
  2. Descendant · cites it directly · 1 of its ownK043574 Allient Sorbent Hemodialysis System, Model 1000Renal Solutions, Inc. · 2005
  3. Descendant · 2 generations on · 0 of its ownK060381 Allient Sorbet Hemodialysis System, Model 1100Renal Solutions, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K043574Allient Sorbent Hemodialysis System, Model 1000Renal Solutions, Inc. · 2005 · cites it directly1descendant
  • K060381Allient Sorbet Hemodialysis System, Model 1100Renal Solutions, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882428REDY 2000Organon Teknika Corp.1988—
+1K043574Allient Sorbent Hemodialysis System, Model 1000Renal Solutions, Inc.2005—
+2K060381Allient Sorbet Hemodialysis System, Model 1100Renal Solutions, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
FIG. 1 — Lineage of K882428, 1988–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 FKT? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K043574Allient Sorbent Hemodialysis System, Model 1000Renal Solutions, Inc.20051

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, K043574 (Renal Solutions, Inc., 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FKT devices

FKT System, Dialysate Delivery, Sorbent Regenerated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKT

1in 2013

2007: 12010: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FKT

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

Recalls per year · FKT

No recall names FKT since 2007.

Adverse event reports per year · FKT

1in 2012

2008: 12010: 12011: 12012: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code FKT, 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
20071—00
20080—01
20090—00
20101—01
20110—01
20120—01
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Organon Teknika Corp.

186 FDA decisions under this applicant name. See the company

  • K003104Bact/Alert CSROrganon Teknika Corp. · 2000
  • K000492Mda D-DimerOrganon Teknika Corp. · 2000
  • K000378Bact/Alert MB Culture BottleOrganon Teknika Corp. · 2000
  • K994343Bact/Alert SVOrganon Teknika Corp. · 2000
  • K993423Bact/Alert SAOrganon Teknika Corp. · 1999

Recent decisions in FKT

The FKT category page

  • K1238352008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2013
  • K0933622008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2010
  • K070739Allient Sorbent Hemodialysis System, Model# 1500Renal Solutions, Inc. · 2007
  • K060381Allient Sorbet Hemodialysis System, Model 1100Renal Solutions, Inc. · 2006
  • K043574Allient Sorbent Hemodialysis System, Model 1000Renal Solutions, Inc. · 2005

https://510kreport.com/device/K882428 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882428: REDY 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882428

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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