510(k) · Cleared
ClearedDimension Drug Calibrator II, Model DC49C
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 Oct 6, 2003 as substantially equivalent to K990255 (Dade Behring, Inc., 1999) after a 47-day review. Its family tree reaches back 2 generations to 1989. 9 later devices descend from it.
- Decided
- Oct 6, 2003
- Review
- 47 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891093 (1989). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK891093 Aca (R) Digitoxin CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1989
- 1 generation backK990255 Dimension Drug Calibrator II, Model DC49BDade Behring, Inc. · 1999
- This deviceK032574 Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK033809 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension…Dade Behring, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK160202 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 0 of its ownK222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891093 | Aca (R) Digitoxin Calibrator | E.I. Dupont DE Nemours & Co., Inc. | 1989 | — |
| −1 | K990255 | Dimension Drug Calibrator II, Model DC49B | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K032574 | Dimension Drug Calibrator II, Model DC49C | Dade Behring, Inc. | 2003 | — |
| +1 | K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug… | Dade Behring, Inc. | 2004 | — |
| +2 | K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +2 | K061655 | Dimension Vista Flex Reagent Cartridges | Dade Behring, Inc. | 2006 | 7 |
| +3 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +3 | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica… | Siemens Healthcare Diagnostics | 2017 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K990255 | Dimension Drug Calibrator II, Model DC49BSummary page 1…g Calibrator I1 (DC49C) FDA Classification Name: Calibrator, drug mixture (91DKB) Predicate Device: Dimension@ Drug Calibrator I1 (DC49B) [K990255]. Device Description: The predicate Drug Calibrator I1 product labeling is being modified to… | 1999 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II… | 2004 | 8 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033809 (Dade Behring, Inc., 2004) has gone furthest, with 8 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 Dade Behring Dimension0 Drug Calibrator II is a device intended for medical purposes for use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens. The product is intended for the calibration of the following methods packaged in Dimension® Flex® reagent cartridges:
Acetaminophen (ACTM)
Carbamazepine (CRBM)
Digitoxin (DGTX)
Gentamicin (GENT)
N-acetylprocainamide (NAPA)
Procainamide (PROC)
Tobramycin (TOBR)
Valproic acid (VALP)
Vancomycin (VANC)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032574: Dimension Drug Calibrator II, Model DC49C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032574
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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