510(k) · Cleared
ClearedDimension Drug Calibrator II, Model DC49B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DKB Calibrators, Drug Mixture
Cleared on Feb 16, 1999 as substantially equivalent to K891093 (E.I. Dupont DE Nemours & Co., Inc., 1989) after a 20-day review. Its family tree reaches back 1 generation to 1989. 10 later devices descend from it.
- Decided
- Feb 16, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891093 (1989). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK891093 Aca (R) Digitoxin CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1989
- This deviceK990255 Dimension Drug Calibrator II, Model DC49BDade Behring, Inc. · 1999
- Descendant · cites it directly · 9 of its ownK032574 Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003
- Descendant · 2 generations on · 8 of its ownK033809 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension…Dade Behring, Inc. · 2004
- Descendant · 3 generations on · 2 of its ownK160202 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 0 of its ownK222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K032574Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003 · cites it directly9descendants
- K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…Dade Behring, Inc. · 2004 · 2 generations on8descendants
- K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc. · 2016 · 3 generations on2descendants
- K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · 3 generations on1descendant
- K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891093 | Aca (R) Digitoxin Calibrator | E.I. Dupont DE Nemours & Co., Inc. | 1989 | — |
| 0 (this device) | K990255 | Dimension Drug Calibrator II, Model DC49B | Dade Behring, Inc. | 1999 | — |
| +1 | K032574 | Dimension Drug Calibrator II, Model DC49C | Dade Behring, Inc. | 2003 | — |
| +2 | K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug… | Dade Behring, Inc. | 2004 | — |
| +3 | K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +3 | K061655 | Dimension Vista Flex Reagent Cartridges | Dade Behring, Inc. | 2006 | 7 |
| +4 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKB? 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K891093 | Aca (R) Digitoxin CalibratorSummary page 1…vice: Cathy P. Craft Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101. | January 22, 1999 Dimension® Drug Calibrator II Calibrator aca® Digitoxin Calibrator, K891093 Device Description: The Dimension® Drug Calibrator II is a liquid bovine serum-based product. The kit consists of ten vials; two… | 1989 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032574 | Dimension Drug Calibrator II, Model DC49C | 2003 | 9 |
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?
- Its one ancestor has no recall.
- Of its descendants, K032574 (Dade Behring, Inc., 2003) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension ®Drug Calibrator 11 is an in vitro diagnostic product intended for the calibration of the following methods packages in Flex™ reagent cartridges:
Acetominophen (ACTM)
Carbamazepine (CRBM)
Digitoxin (DGTX)
Gentamicin (GENT)
Tobramycin (TOBR)
Valproic Acid (VALP)
Vancomycin (VANC)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990255: Dimension Drug Calibrator II, Model DC49B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990255
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026