510(k) · Cleared
ClearedBD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson and Company · JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Cleared on Sep 14, 2026 as substantially equivalent to K963036 (Becton Dickinson Microbiology Systems, 1996) after an 80-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Sep 14, 2026
- Review
- 80 days
- Class
- Class II
- Product code
- JTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913459 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK913459 The E Test, ModificationAb Biodisk · 1991 · Recalled
- 1 generation backK963036 Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse BloodBecton Dickinson Microbiology Systems · 1996
- This deviceK262163 BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller…Becton Dickinson and Company · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913459 | The E Test, Modification | Ab Biodisk | 1991 | 6 |
| −1 | K963036 | Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood | Becton Dickinson Microbiology Systems | 1996 | — |
| 0 (this device) | K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson and Company | 2026 | — |
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 JTZ? 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 |
|---|---|---|---|
| * | K963036 | Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse BloodSummary page 8…edicate Device Name: BD BBL™ Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood B. Predicate 510(k) Number: K963036 C. Comparison of the Predicate Device to the Candidate Device: The similarities and differences of… | 1996 |
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 35 years and passes through 3 companies; a new generation was cleared every 29.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JTZ devicesJTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JTZ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · JTZ
Too few JTZ 510(k)s in any year since 2007 to give a median.
Recalls per year · JTZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTZ
20in 2025
MAUDE reports naming product code JTZ, 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 | — | 1 | 1 |
| 2009 | 0 | — | 2 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 1 | 20 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
BD BBL Mueller Hinton II Broth (Cation-Adjusted) is intended for use in manual, quantitative procedures for susceptibility testing of rapidly-growing aerobic and facultatively anaerobic bacteria isolated from clinical specimens. It is formulated to have a low thymine and thymidine content and is adjusted to the calcium and magnesium ion concentrations recommended by the Clinical and Laboratory Standards Institute (CL.SI). BD BBL Mueller Hinton II Broth…
Read the full statement (203 words)
BD BBL Mueller Hinton II Broth (Cation-Adjusted) is intended for use in manual, quantitative procedures for
susceptibility testing of rapidly-growing aerobic and facultatively anaerobic bacteria isolated from clinical specimens. It is
formulated to have a low thymine and thymidine content and is adjusted to the calcium and magnesium ion concentrations
recommended by the Clinical and Laboratory Standards Institute (CL.SI). BD BBL Mueller Hinton II Broth (Cation-
Adjusted) functions as an aid to diagnosis using pure culture isolates. BD BBL Mueller Hinton Il Broth (Cation-Adjusted)
is available as either a dehydrated culture medium, which is prepared as a broth prior to use, or as a ready-to-use broth.
BD Difco Mueller Hinton Broth, not cation-adjusted, is intended for use in manual, quantitative procedures for
susceptibility testing of rapidly-growing aerobic and facultatively anaerobic bacteria isolated from clinical specimens as
long as the calcium and magnesium ion concentrations are adjusted as recommended by the Clinical and Laboratory
Standards Institute (CLSI). It is formulated to have a low thymine and thymidine content. BD Difco Mueller Hinton Broth
functions as an aid to diagnosis using pure culture isolates. BD Difco Mueller Hinton Broth is available as a dehydrated
culture medium which is prepared as a broth prior to use.
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/K262163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262163: BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262163
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026