510(k) · Cleared
Recalled · Class II · 2018Mueller Hinton Agar W/4% Nacl W/Antibiotics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel Co. · JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Cleared on May 10, 1985 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- May 10, 1985
- Review
- 106 days
- Class
- Class II
- Product code
- JTZ
- Recalls
- 2
- Predicates
- 0
22 later devices descend from it, 3 citing it directly.
- This deviceK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985
- Descendant · cites it directly · 14 of its ownK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · Recalled
- Descendant · 2 generations on · 10 of its ownK070462 Xpert MrsaCepheid · 2007 · Recalled
- Descendant · 3 generations on · 7 of its ownK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · Recalled
- Descendant · 4 generations on · 4 of its ownK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK091766 Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K033415Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · cites it directly14descendants
- K070462Xpert MrsaCepheid · 2007 · 2 generations on10descendants
- K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · 3 generations on7descendants
- K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · 4 generations on4descendants
- K091766Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | — |
| +1 | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | 1 |
| +2 | K070462 | Xpert Mrsa | Cepheid | 2007 | 1 |
| +3 | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | 2 |
| +4 | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | 4 |
| +1 | K091766 | Clearview Exact PBP2A Test, Model 891-000 | Binax, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
Top candidate predicates for a new JTZ device
- #1 K262163 BD BBL Mueller Hinton II Broth…score 12.3 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2018 | Class II | Z-2137-2018 | Under Investigation by firm | Product may fail performance testing for S aureus ATCC 43300. |
| Dec 8, 2009 | Not classified | Z-0644-2010 | Nonconforming Material/Component | The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033415 (Infectio Diagnostic (I.D.I.), Inc., 2004) has gone furthest, with 14 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K850291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K850291: Mueller Hinton Agar W/4% Nacl W/Antibiotics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850291
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026