510(k) Report

510(k) · Cleared

Cleared

Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132

K011033510(k) TraditionalCleared Jun 7, 200163-day reviewClass II21 CFR 862.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · JIH Flame Photometry, Lithium

Cleared on Jun 7, 2001 after a 63-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
Jun 7, 2001
Review
63 days
Class
Class II
Product code
JIH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2011: 1 descendant cleared200020052010201520202025
  1. This deviceK011033 Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK112142 Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2011 · Recalled
  3. Descendant · cites it directly · 0 of its ownK061792 Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp)…Dade Behring, Inc. · 2006 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K112142Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2011 · cites it directly0descendants
  • K061792Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011033Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132Dade Behring, Inc.2001—
+1K112142Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics20111
+1K061792Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0…Dade Behring, Inc.20062

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201110
FIG. 1 — Lineage of K011033, 2001–2011Source: 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 JIH? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K112142Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics20110
K061792Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…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, K112142 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JIH devices

JIH Flame Photometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIH

FDA has decided no JIH device since 2007.

Median 510(k) review, days · JIH

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

Recalls per year · JIH

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JIH

5in 2025

2011: 12012: 22013: 22014: 12018: 22021: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code JIH, 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
20090—00
20100—00
20110—01
20120—02
20130—12
20140—01
20150—00
20160—00
20170—00
20180—02
20190—00
20200—00
20210—01
20220—00
20230—00
20240—01
20250—05
20260—0—

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in JIH

The JIH category page

  • K050338Modification to: Instaread Lithium SystemAkers Biosciences, Inc. · 2005
  • K031579Instaread Lithium SystemAkers Laboratories, Inc. · 2003
  • K934106Kodak Ektachem DTSC II Slides (LI)Eastman Kodak Company · 1994
  • K924488Kodak Ektachem Clinical Chemistry Slides (LI)Eastman Kodak Company · 19932 recalls
  • K921403Model 654 AnalyzerCiba Corning Diagnostics Corp. · 1992

https://510kreport.com/device/K011033 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011033: Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011033

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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