510(k) Report

510(k) · Decided

Decided

REDY 2000

K840743510(k) TraditionalDecided Feb 6, 19840-day review

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

Organon Teknika Corp.

Cleared on Feb 6, 1984 after a 0-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
Feb 6, 1984
Review
0 days
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared19801990200020102020
  1. This deviceK840743 REDY 2000Organon Teknika Corp. · 1984
  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)K840743REDY 2000Organon Teknika Corp.1984—
+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 K840743, 1984–2006Source: 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.

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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.

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

https://510kreport.com/device/K840743 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840743: 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/K840743

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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