510(k) Report

510(k) · Cleared

Cleared

Dupont Dimension (R) Pseudocholinesterase Method

K950180510(k) TraditionalCleared Mar 15, 199557-day reviewClass I21 CFR 862.3240

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. · DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

Cleared on Mar 15, 1995 after a 57-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
Mar 15, 1995
Review
57 days
Class
Class I
Product code
DLI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950180 Dupont Dimension (R) Pseudocholinesterase MethodE.I. Dupont DE Nemours & Co., Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · cites it directly1descendant
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950180Dupont Dimension (R) Pseudocholinesterase MethodE.I. Dupont DE Nemours & Co., Inc.1995—
+1K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20067
+2K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium…Siemens Healthcare Diagnostics20152

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201510
FIG. 1 — Lineage of K950180, 1995–2015Source: 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.

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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
K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20061

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, K061655 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DLI devices

DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DLI

FDA has decided no DLI device since 2007.

Median 510(k) review, days · DLI

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

Recalls per year · DLI

No recall names DLI since 2007.

Adverse event reports per year · DLI

No MAUDE report names DLI 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 DLI

The DLI category page

  • K930208Cholinesterase Method for Technicon CHEM1/TechnicoHeraeus Kulzer, Inc. · 1993
  • K860350Serum Cholinesterase Reagent SetSterling Diagnostics, Inc. · 1986
  • K860641Easy-Test (Che) Reagent, Item NO. 67522/93Em Diagnostic Systems, Inc. · 1986
  • K833062Serum Cholinesterase Reagent SetSterling Biochemical, Inc. · 1983
  • K771024Cholinesterase Reagent SystemAmerican Monitor Corp. · 1977

https://510kreport.com/device/K950180 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950180: Dupont Dimension (R) Pseudocholinesterase Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950180

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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