510(k) Report

510(k) · Cleared

Cleared

Dimension (TM) Clinical Chemistry System

K864230510(k) TraditionalCleared Nov 28, 198631-day reviewClass II21 CFR 862.1020

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

E.I. Dupont DE Nemours & Co., Inc. · CKE Acid Phosphatase, Thymolphthale Inmonophosphate

Cleared on Nov 28, 1986 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Nov 28, 1986
Review
31 days
Class
Class II
Product code
CKE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2000: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK864230 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
  2. Descendant · cites it directly · 2 of its ownK994115 Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc. · 2000 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK061020 Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino…Dade Behring, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK052867 Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K994115Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc. · 2000 · cites it directly2descendants
  • K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc. · 2006 · 2 generations on0descendants
  • K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864230Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc.1986—
+1K994115Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc.20002
+2K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc.20061
+2K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200510
200610
FIG. 1 — Lineage of K864230, 1986–2006Source: 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.

Planning a device in CKE? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K994115Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc.20002

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, K994115 (Dade Behring, Inc., 2000) has gone furthest, with 2 descendants of its own.

How does its category compare?

All CKE devices

CKE Acid Phosphatase, Thymolphthale Inmonophosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKE

FDA has decided no CKE device since 2007.

Median 510(k) review, days · CKE

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

Recalls per year · CKE

No recall names CKE since 2007.

Adverse event reports per year · CKE

No MAUDE report names CKE since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—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 E.I. Dupont DE Nemours & Co., Inc.

253 FDA decisions under this applicant name. See the company

  • K951851Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayE.I. Dupont DE Nemours & Co., Inc. · 1996
  • K953724Cronex Radiation Therapy CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K953725Cronex Radiation Therapy Verification CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K951441Dupont Aca Digoxin (DGN a) MethodE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K950137Urine Barbiturates Screen Flex (TM) Reagent CartridgeE.I. Dupont DE Nemours & Co., Inc. · 1995

Recent decisions in CKE

The CKE category page

  • K914167Clinical Chem.Anal.Acid,Prostatic Acid PhosphataseEastman Kodak Company · 1992
  • K915705Acid Phosphatase Reagent SetTech Intl. Co. · 1992
  • K873726Acid Phosphatase TestKing Diagnostics, Inc. · 1988
  • K860476Acid Phosphatase Reagent SetSterling Diagnostics, Inc. · 1986
  • K843380Acid Phosphatase Assay KitDiagnostic Chemicals, Ltd. (Usa) · 1984

https://510kreport.com/device/K864230 · printed Nov 6, 2026

Cite this page

510(k) Report. “K864230: Dimension (TM) Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864230

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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