# K850291: Mueller Hinton Agar W/4% Nacl W/Antibiotics

- Pathway: 510(k) (Traditional)
- Applicant: Remel Co.
- Decided: May 10, 1985 after 106 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033415: Idi-Mrsa (2004), 14 descendants of its own
- K070462: Xpert Mrsa (2007), 10 descendants of its own
- K093346: BD Geneohm Mrsa Acp Assay (2009), 7 descendants of its own
- K120138: BD Max Mrsa Assay, BD Max Instrument (2012), 4 descendants of its own
- K091766: Clearview Exact PBP2A Test, Model 891-000 (2010), 4 descendants of its own

## Recalls of this device
- May 4, 2018 · Class II · Z-2137-2018: Product may fail performance testing for S aureus ATCC 43300.
- Dec 8, 2009 · Not classified · Z-0644-2010: The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.

Source page: https://510kreport.com/device/K850291
Methodology: https://510kreport.com/methodology