510(k) · Cleared
ClearedCedia Antibiotic TDM Multi-Cals
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DKB Calibrators, Drug Mixture
Cleared on Sep 10, 1996 as substantially equivalent to K912143 (Microgenics Corp., 1991) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 10, 1996
- Review
- 26 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912143 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912143 Cedia (R) Tobramycin AssayMicrogenics Corp. · 1991 · Recalled
- This deviceK963191 Cedia Antibiotic TDM Multi-CalsBoehringer Mannheim Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912143 | Cedia (R) Tobramycin Assay | Microgenics Corp. | 1991 | 2 |
| 0 (this device) | K963191 | Cedia Antibiotic TDM Multi-Cals | Boehringer Mannheim Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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? (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 |
|---|---|---|---|
| * | K912143 | Cedia (R) Tobramycin AssaySummary page 1…me: Calibrators, drug mixture The Boehringer Mannheim CEDIA Antibiotic TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA tobramycin (K912143) and gentamicin (K913470) assays. The CEDIA Antibiotic TDM Calibrators are manufactured using bovine serum albumin, tobramycin,… | 1991 |
| * | K913470 | Cedia (R) Gentamicin AssaySummary page 1…ture The Boehringer Mannheim CEDIA Antibiotic TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA tobramycin (K912143) and gentamicin (K913470) assays. The CEDIA Antibiotic TDM Calibrators are manufactured using bovine serum albumin, tobramycin, gentamicin, stabilizers,… | 1991 |
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?
- 1 of the 2 ancestors has a recall of any class.
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 CEDIA Antibiotic TDM Multi-Cals are used to calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma.
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/K963191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963191: Cedia Antibiotic TDM Multi-Cals.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963191
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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