510(k) Report

510(k) · Cleared

Cleared

Lidocaine Analytical Test Pack Aca

K833379510(k) TraditionalCleared Dec 27, 198389-day reviewClass II21 CFR 862.3555

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. · KLR Enzyme Immunoassay, Lidocaine

Cleared on Dec 27, 1983 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Dec 27, 1983
Review
89 days
Class
Class II
Product code
KLR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2016: 1 descendant cleared2006: 2 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2023: 1 descendant cleared2017: 1 descendant cleared19801990200020102020
  1. This deviceK833379 Lidocaine Analytical Test Pack AcaE.I. Dupont DE Nemours & Co., Inc. · 1983
  2. Descendant · cites it directly · 8 of its ownK033809 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension…Dade Behring, Inc. · 2004
  3. Descendant · 2 generations on · 2 of its ownK160202 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3…Siemens Healthcare Diagnostics, Inc. · 2016
  4. Descendant · 2 generations on · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023
  6. Descendant · 3 generations on · 0 of its ownK161954 Atellica Solution, Atellica A-LYTE Integrated Multisensor…Siemens Healthcare Diagnostics · 2017 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22009: 12010: 12015: 12016: 12017: 12023: 1
2004high 2 (2006) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…Dade Behring, Inc. · 2004 · cites it directly8descendants
  • K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on2descendants
  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · 2 generations on1descendant
  • K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023 · 3 generations on0descendants
  • K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K833379Lidocaine Analytical Test Pack AcaE.I. Dupont DE Nemours & Co., Inc.1983—
+1K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug…Dade Behring, Inc.2004—
+2K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc.2016—
+2K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20067
+3K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc.2023—
+3K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica…Siemens Healthcare Diagnostics20178

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200910
201010
201510
201610
201710
202310
FIG. 1 — Lineage of K833379, 1983–2023Source: 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 KLR? 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? (9)

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

NumberDeviceApplicantDecidedDescendants
K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…Dade Behring, Inc.20048

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, K033809 (Dade Behring, Inc., 2004) has gone furthest, with 8 descendants of its own.

How does its category compare?

All KLR devices

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

FDA decisions per year · KLR

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLR

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

Recalls per year · KLR

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · KLR

2in 2020

2020: 2
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code KLR, 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—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—1—

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 KLR

The KLR category page

  • K090282QMS LidocaineThermo Fisher Scientific, Inc. · 2009
  • K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49DDade Behring, Inc. · 2004
  • K032334Roche Online TDM LidocaineRoche Diagnostics Corp. · 2004
  • K973102Lidocaine Eia AssayDiagnostic Reagents, Inc. · 1997
  • K881116Easy-Test Emit (R) Lidocaine Lido Item NO. 16641Diagnostic Systems · 1988

https://510kreport.com/device/K833379 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833379: Lidocaine Analytical Test Pack Aca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833379

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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