# K132491: Mueller Hinton Agar

- Pathway: 510(k) (Traditional)
- Applicant: Edge Biologicals, Inc.
- Decided: Jun 30, 2014 after 326 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: 1 generation back to K960420 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960420: Mueller Hinton Agar with 5% Sheep Blood, Becton Dickinson Microbiology Systems (1996) Summary page 1.

## Indications for use
Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibility testing of isolated colonies of common, rapidly growing bacteria by the Bauer-Kirby method as standardized by the Clinical and Laboratory Standards Institute (OLSI). This product has not been evaluated for gradient diffusion testing.

Source page: https://510kreport.com/device/K132491
Methodology: https://510kreport.com/methodology