510(k) Report

510(k) · Cleared

Cleared

Methods for the Dimension Clinical Chem. System

K862955510(k) TraditionalCleared Sep 25, 198651-day reviewClass II21 CFR 862.3880

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. · KLS Enzyme Immunoassay, Theophylline

Cleared on Sep 25, 1986 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 25, 1986
Review
51 days
Class
Class II
Product code
KLS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared1990200020102020
  1. This deviceK862955 Methods for the Dimension Clinical Chem. SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
  2. Descendant · cites it directly · 0 of its ownK062024 Dimension Vista Digitoxin, Digoxin, Gentamicin…Dade Behring, Inc. · 2006 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K062024Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862955Methods for the Dimension Clinical Chem. SystemE.I. Dupont DE Nemours & Co., Inc.1986—
+1K062024Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide…Dade Behring, Inc.20064

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K862955, 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 KLS? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K062024Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…Dade 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, K062024 (Dade Behring, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KLS devices

KLS Enzyme Immunoassay, Theophylline: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLS

FDA has decided no KLS device since 2007.

Median 510(k) review, days · KLS

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

Recalls per year · KLS

2in 2013

2012: 22013: 2
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KLS

1in 2025

2007: 12009: 22011: 12016: 22025: 1
2007high 2 (2009) · low 0 (2008)2025

MAUDE reports naming product code KLS, 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—01
20080—00
20090—02
20100—00
20110—01
20120—20
20130—20
20140—00
20150—00
20160—02
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
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 KLS

The KLS category page

  • K042520Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc. · 2004
  • K042407Emit Caffeine AssayDade Behring, Inc. · 2004
  • K020740Roche Online TheophyllineRoche Diagnostics Corp. · 2002
  • K011771Randox TheophyllineRandox Laboratories, Ltd. · 2002
  • K013272Acs: 180 and Advia Centaur Theophylline 2 AssayBayer Corp. · 2001

https://510kreport.com/device/K862955 · printed Nov 5, 2026

Cite this page

510(k) Report. “K862955: Methods for the Dimension Clinical 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/K862955

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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