510(k) Report

510(k) · Cleared

Cleared

Dimension Drug Calibrator, Model DC22B

K011035510(k) TraditionalCleared Jun 14, 200170-day reviewClass II21 CFR 862.1150

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

Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Jun 14, 2001 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Jun 14, 2001
Review
70 days
Class
Class II
Product code
JIX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 2 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2005: 1 descendant cleared2015: 2 descendants cleared2008: 2 descendants cleared200020052010201520202025
  1. This deviceK011035 Dimension Drug Calibrator, Model DC22BDade Behring, Inc. · 2001
  2. Descendant · cites it directly · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
  4. Descendant · 2 generations on · 1 of its ownK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK143720 Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22008: 22010: 22011: 12015: 2
2005high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · cites it directly5descendants
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 2 generations on1descendant
  • K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · 2 generations on1descendant
  • K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011035Dimension Drug Calibrator, Model DC22BDade Behring, Inc.2001—
+1K051087Dimension Vista Integrated SystemDade Behring, Inc.200532
+2K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—
+2K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc.20063
+2K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics20155
+3K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium…Siemens Healthcare Diagnostics20152

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200820
201020
201110
201520
FIG. 1 — Lineage of K011035, 2001–2015Source: 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.

Planning a device in JIX? 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? (10)

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

NumberDeviceApplicantDecidedDescendants
K051087Dimension Vista Integrated SystemDade Behring, Inc.20055
K112142Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics20110
K093441Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435Siemens Healthcare Diagnostics20100
K093732Advia Chemistry Drug Calibrator I Model 10376770Siemens Healthcare Diagnostics20100
K062034Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410)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, K051087 (Dade Behring, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIX

1in 2016

2007: 62008: 52009: 42010: 52011: 72012: 22013: 42014: 12015: 32016: 1
2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007: 53 days median2008: 69 days median2009: 121 days median2010: 100 days median2011: 77 days median2013: 50 days median2015: 29 days median
2007high 121 (2009) · low 29 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JIX

7in 2023

2007: 22008: 32009: 22010: 12011: 22012: 12014: 12016: 12017: 12018: 12019: 12020: 22023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2013)2026

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

Adverse event reports per year · JIX

18in 2025

2007: 1402008: 1732009: 392011: 92012: 32013: 242014: 352015: 42016: 62017: 172018: 162019: 122020: 222021: 92022: 112023: 132024: 152025: 18
2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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
20076532140
20085693173
20094121239
2010510010
201177729
20122—13
2013450024
20141—135
201532904
20161—16
20170—117
20180—116
20190—112
20200—222
20210—09
20220—011
20230—713
20240—015
20250—018
20260—1—

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 JIX

The JIX category page

  • K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc. · 2016
  • K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup · 2015
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics · 20152 recalls
  • K141388System CalibraterBeckman Coulter Ireland, Inc. · 2014

https://510kreport.com/device/K011035 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011035: Dimension Drug Calibrator, Model DC22B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011035

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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