510(k) · Cleared
ClearedDimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · KLR Enzyme Immunoassay, Lidocaine
Cleared on Feb 20, 2004 as substantially equivalent to K833379 (E.I. Dupont DE Nemours & Co., Inc., 1983) and 1 other predicate after a 74-day review. Its family tree reaches back 3 generations to 1989. 8 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 74 days
- Class
- Class II
- Product code
- KLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K891093 (1989). 4 ancestors in all, the oldest K833379 (1983). 8 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK891093 Aca (R) Digitoxin CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1989
- 2 generations backK990255 Dimension Drug Calibrator II, Model DC49BDade Behring, Inc. · 1999
- 1 generation backK032574 Dimension Drug Calibrator II, Model DC49CDade Behring, Inc. · 2003
- This deviceK033809 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension…Dade Behring, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK160202 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK161954 Atellica Solution, Atellica A-LYTE Integrated Multisensor…Siemens Healthcare Diagnostics · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc. · 2016 · cites it directly2descendants
- K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · cites it directly1descendant
- K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics · 2017 · 2 generations on0descendants
- K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891093 | Aca (R) Digitoxin Calibrator | E.I. Dupont DE Nemours & Co., Inc. | 1989 | — |
| −2 | K990255 | Dimension Drug Calibrator II, Model DC49B | Dade Behring, Inc. | 1999 | — |
| −1 | K032574 | Dimension Drug Calibrator II, Model DC49C | Dade Behring, Inc. | 2003 | — |
| 0 (this device) | K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug… | Dade Behring, Inc. | 2004 | — |
| +1 | K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +1 | K061655 | Dimension Vista Flex Reagent Cartridges | Dade Behring, Inc. | 2006 | 7 |
| +2 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +2 | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica… | Siemens Healthcare Diagnostics | 2017 | 8 |
| +2 | K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium… | Siemens Healthcare Diagnostics | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KLR? 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? (2)
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 |
|---|---|---|---|
| * | K833379 | Lidocaine Analytical Test Pack AcaSummary page 1…sification Name(s): Lidocaine test system (Class II) and Calibrator (Class II) Predicate Device(s): Dade Behring aca® LIDO analytical test pack [K833379] and Dade Behring Dimension® Drug Calibrator II (DC49C) [K032574] Device Description(s): M… | 1983 |
| * | K032574 | Dimension Drug Calibrator II, Model DC49CSummary page 1…vice(s): Dade Behring aca® LIDO analytical test pack [K833379] and Dade Behring Dimension® Drug Calibrator II (DC49C) [K032574] Device Description(s): Method The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diag… | 2003 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | 2016 | 2 |
| K061655 | Dimension Vista Flex Reagent Cartridges | 2006 | 1 |
| K103360 | Dimension Vista Digitoxin Calibrator - DGTX Cal | 2010 | 0 |
| K090900 | Advia Chemistry Drug Calibrator II, Model 10376771 | 2009 | 0 |
| K062121 | Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - KC420) | 2006 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K160202 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KLR devicesKLR Enzyme Immunoassay, Lidocaine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLR
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · KLR
Too few KLR 510(k)s in any year since 2007 to give a median.
Recalls per year · KLR
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLR
2in 2020
MAUDE reports naming product code KLR, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method on the Dimension® clinical chemistry system is for the quantitative determination of lidocaine in serum or plasma. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring.
The Dade Behring Dimension® Drug Calibrator II (DC49D) is a device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033809 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033809
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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