510(k) · Cleared
ClearedQMS Lidocaine Calibrators, Model 0374678
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · DLJ Calibrators, Drug Specific
Cleared on Jul 17, 2009 as substantially equivalent to K031856 (Roche Diagnostics Corp., 2003) after a 44-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Jul 17, 2009
- Review
- 44 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842280 (1984). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 2 generations backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- 1 generation backK031856 Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp. · 2003 · Recalled
- This deviceK091617 QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −2 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| −1 | K031856 | Preciset TDM I and Preciset TDM II Calibrators | Roche Diagnostics Corp. | 2003 | 2 |
| 0 (this device) | K091617 | QMS Lidocaine Calibrators, Model 0374678 | Thermo Fisher Scientific | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 8 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 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 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
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 |
|---|---|---|---|
| * | K031856 | Preciset TDM I and Preciset TDM II CalibratorsSummary page 1…ibrator set is intended for use in calibration of the QMS Lidocaine assay. LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED Roche Preciset TDM II Calibrators K031856 DESCRIPTION OF DEVICE The QMS Lidocaine Calibrator set is a six-level set (0, 0.5, 1.0, 2.5, 5.0, 10 pglmL) of single analyte (l… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 4 of the 22 ancestors have a recall of any class.
How does its category compare?
All DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DLJ
1in 2013
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091617: QMS Lidocaine Calibrators, Model 0374678.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091617
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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