510(k) Report

510(k) · Cleared

Cleared

Cyclosporine Calibrator

K011112510(k) TraditionalCleared Jul 17, 200197-day reviewClass II21 CFR 862.3200

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

Dade Behring, Inc. · DLJ Calibrators, Drug Specific

Cleared on Jul 17, 2001 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Jul 17, 2001
Review
97 days
Class
Class II
Product code
DLJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2006: 3 descendants cleared2008: 1 descendant cleared200020052010201520202025
  1. This deviceK011112 Cyclosporine CalibratorDade Behring, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK052015 Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Dade Behring, Inc. · 2005
  3. Descendant · 2 generations on · 2 of its ownK053108 Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108Dade Behring, Inc. · 2006
  4. Descendant · 2 generations on · 1 of its ownK061503 Dimension Cyclosporine Extended Range Calibrator (DC108A)Dade Behring, Inc. · 2006
  5. Descendant · 3 generations on · 0 of its ownK082030 Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc. · 2008
  6. Descendant · cites it directly · 0 of its ownK062199 Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)Dade Behring, Inc. · 2006

Most influential descendants

Showing 5 of 5 · See all
  • K052015Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Dade Behring, Inc. · 2005 · cites it directly3descendants
  • K053108Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108Dade Behring, Inc. · 2006 · 2 generations on2descendants
  • K061503Dimension Cyclosporine Extended Range Calibrator (DC108A)Dade Behring, Inc. · 2006 · 2 generations on1descendant
  • K082030Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc. · 2008 · 3 generations on0descendants
  • K062199Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011112Cyclosporine CalibratorDade Behring, Inc.2001—
+1K052015Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Dade Behring, Inc.2005—
+2K053108Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108Dade Behring, Inc.2006—
+2K061503Dimension Cyclosporine Extended Range Calibrator (DC108A)Dade Behring, Inc.2006—
+3K082030Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc.2008—
+1K062199Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)Dade Behring, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200630
200810
FIG. 1 — Lineage of K011112, 2001–2008Source: 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 DLJ? 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
Get a 510(k) Report

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? (5)

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

NumberDeviceApplicantDecidedDescendants
K052015Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Dade Behring, Inc.20053
K062199Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)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, K052015 (Dade Behring, Inc., 2005) has gone furthest, with 3 descendants of its own.

How does its category compare?

All DLJ devices

DLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DLJ

1in 2013

2008: 12009: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DLJ

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

Recalls per year · DLJ

2in 2011

2010: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DLJ

3in 2025

2011: 62012: 52013: 12017: 12018: 22020: 12022: 12024: 12025: 3
2007high 6 (2011) · low 0 (2007)2025

MAUDE reports naming product code DLJ, 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
20081—00
20091—00
20100—10
20110—26
20120—05
20131—01
20140—00
20150—00
20160—00
20170—01
20180—02
20190—00
20200—01
20210—00
20220—01
20230—00
20240—01
20250—03
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 DLJ

The DLJ category page

  • K132090Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2Randox Laboratories, Ltd. · 2013
  • K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009
  • K082030Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc. · 2008
  • K062182Dimension Vista System Ecstasy Calibrator, Model KC520Dade Behring, Inc. · 2006
  • K062199Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)Dade Behring, Inc. · 2006

https://510kreport.com/device/K011112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011112: Cyclosporine Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011112

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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