# K262163: BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson and Company
- Decided: Sep 14, 2026 after 80 days
- Product code: JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth)
- Device class: 2
- Regulation: 21 CFR 866.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913459 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963036: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood, Becton Dickinson Microbiology Systems (1996) Summary page 8.

## Indications for use
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.

Source page: https://510kreport.com/device/K262163
Methodology: https://510kreport.com/methodology