510(k) Report

510(k) · Cleared

Cleared

Meth. & Cali. for the Dimension Clini/Chem. System

K863840510(k) TraditionalCleared Nov 5, 198635-day reviewClass I21 CFR 862.2160

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 Nov 5, 1986 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Nov 5, 1986
Review
35 days
Class
Class I
Product code
JJE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 2 descendants cleared2000: 1 descendant cleared2006: 3 descendants cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK863840 Meth. & Cali. for the Dimension Clini/Chem. SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
  2. Descendant · cites it directly · 2 of its ownK994114 Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc. · 2000
  3. Descendant · cites it directly · 0 of its ownK123677 Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3…Siemens Healthcare Diagnostics · 2013 · Recalled
  4. Descendant · cites it directly · 0 of its ownK123320 Dimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2013 · Recalled
  5. Descendant · cites it directly · 0 of its ownK062316 Dimension Vista Ammonia (Amon) Flex Reagent CartridgeDade Behring, Inc. · 2006
  6. Descendant · cites it directly · 0 of its ownK062152 Creatinine Kinase MB Isoenzyme Verifier, Model DC27Dade Behring, Inc. · 2006

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2000: 12005: 12006: 32013: 2
2000high 3 (2006) · low 0 (2001)2026

Most influential descendants

Showing 5 of 7 · See all
  • K994114Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc. · 2000 · cites it directly2descendants
  • K123677Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)Siemens Healthcare Diagnostics · 2013 · cites it directly0descendants
  • K123320Dimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2013 · cites it directly0descendants
  • K062316Dimension Vista Ammonia (Amon) Flex Reagent CartridgeDade Behring, Inc. · 2006 · cites it directly0descendants
  • K062152Creatinine Kinase MB Isoenzyme Verifier, Model DC27Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863840Meth. & Cali. for the Dimension Clini/Chem. SystemE.I. Dupont DE Nemours & Co., Inc.1986—
+1K994114Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc.2000—
+1K123677Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator…Siemens Healthcare Diagnostics20131
+1K123320Dimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics20133
+1K062316Dimension Vista Ammonia (Amon) Flex Reagent CartridgeDade Behring, Inc.2006—
+1K062152Creatinine Kinase MB Isoenzyme Verifier, Model DC27Dade Behring, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200510
200630
201320
FIG. 1 — Lineage of K863840, 1986–2013Source: 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K994114Dimension Total Iron Binding Capacity (Ibct) CalibratorDade Behring, Inc.20002
K123677Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)Siemens Healthcare Diagnostics20130
K123320Dimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics20130
K062316Dimension Vista Ammonia (Amon) Flex Reagent CartridgeDade Behring, Inc.20060
K062152Creatinine Kinase MB Isoenzyme Verifier, Model DC27Dade Behring, Inc.20060

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, K994114 (Dade Behring, Inc., 2000) has gone furthest, with 2 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/K863840 · printed Nov 5, 2026

Cite this page

510(k) Report. “K863840: Meth. & Cali. for the Dimension Clini/Chem. System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K863840

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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