510(k) Report

510(k) · Cleared

Recalled · 2011

Dimension (TM) Clinical Chemistry System

K860021510(k) TraditionalCleared Feb 11, 198639-day reviewClass I21 CFR 862.2160Recalls 1

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. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on Feb 11, 1986 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled once.

Decided
Feb 11, 1986
Review
39 days
Class
Class I
Product code
JJE
Recalls
1
Predicates
0

21 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2006: 7 descendants cleared2009: 2 descendants cleared2005: 1 descendant cleared2003: 1 descendant cleared2015: 3 descendants cleared2008: 2 descendants cleared2014: 1 descendant cleared2011: 2 descendants cleared2012: 2 descendants cleared1990200020102020
  1. This deviceK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
  2. Descendant · cites it directly · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
  3. Descendant · cites it directly · 3 of its ownK061390 Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc. · 2006
  4. Descendant · cites it directly · 2 of its ownK061818 Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal -…Dade Behring, Inc. · 2006 · Recalled
  5. Descendant · cites it directly · 2 of its ownK031135 Glucose Flex Reagent Cartridge (Gluc)Dade Behring, Inc. · 2003
  6. Descendant · 2 generations on · 1 of its ownK103612 Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc. · 2011 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 72008: 22009: 22011: 22012: 22014: 12015: 3
2003high 7 (2006) · low 0 (2004)2026

Most influential descendants

Showing 5 of 21 · See all
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · cites it directly5descendants
  • K061390Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc. · 2006 · cites it directly3descendants
  • K061818Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)Dade Behring, Inc. · 2006 · cites it directly2descendants
  • K031135Glucose Flex Reagent Cartridge (Gluc)Dade Behring, Inc. · 2003 · cites it directly2descendants
  • K103612Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K860021Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc.1986—
+1K051087Dimension Vista Integrated SystemDade Behring, Inc.200532
+1K061390Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc.2006—
+1K061818Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)Dade Behring, Inc.20061
+1K031135Glucose Flex Reagent Cartridge (Gluc)Dade Behring, Inc.2003—
+2K103612Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200670
200820
200920
201120
201220
201410
201530
FIG. 1 — Lineage of K860021, 1986–2015Source: 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 JJE? 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? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K051087Dimension Vista Integrated SystemDade Behring, Inc.20055
K061390Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc.20063
K061818Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)Dade Behring, Inc.20062
K031135Glucose Flex Reagent Cartridge (Gluc)Dade Behring, Inc.20032
K061238Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent…Dade Behring, Inc.20061
K090330Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine…Siemens Healthcare Diagnostics, Inc.20090
K083339Dimension RXL Max with Advia Modular Automation System (Amas)Siemens Healthcare Diagnostics, Inc.20090
K061792Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…Dade Behring, Inc.20060
K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 19, 2011Not classifiedZ-3039-2011OtherSiemens Healthcare Diagnostic has confirmed a high frequency of "Abnormal assay" flags and imprecision. Test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dL at a concentration of 9.26 mg/dL.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051087 (Dade Behring, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JJE devices

JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJE

1in 2019

2008: 12011: 22012: 12013: 12014: 32019: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJE

224in 2014

2014: 224 days median
2007high 224 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJE

6in 2025

2007: 202008: 202009: 142010: 322011: 252012: 162013: 212014: 142015: 152016: 92017: 182018: 172019: 72020: 72021: 62023: 122024: 62025: 62026 (partial year): 5
2007high 32 (2010) · low 0 (2022)2026

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

Adverse event reports per year · JJE

4,400in 2025

2007: 2,1812008: 2,1592009: 3,4402010: 3,2732011: 11,6062012: 3,7072013: 2,4892014: 2,8412015: 2,7932016: 2,5802017: 1,8692018: 4,5902019: 3,9482020: 3,9862021: 3,9202022: 3,9982023: 3,7832024: 4,2212025: 4,400
2007high 11,606 (2011) · low 1,869 (2017)2025

MAUDE reports naming product code JJE, 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—202,181
20081—202,159
20090—143,440
20100—323,273
20112—2511,606
20121—163,707
20131—212,489
20143224142,841
20150—152,793
20160—92,580
20170—181,869
20180—174,590
20191—73,948
20200—73,986
20210—63,920
20220—03,998
20230—123,783
20240—64,221
20250—64,400
20260—5—

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 JJE

The JJE category page

  • K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd. · 2019
  • K133519Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, CarCarolina Liquid Chemistries Corp. · 2014
  • K130915XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJas Diagnostics, Inc. · 2014
  • K131554RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) ReagentRandox Laboratories, Ltd. · 20143 recalls
  • K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 20136 recalls

https://510kreport.com/device/K860021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860021: 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/K860021

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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