510(k) · Cleared
Recalled · 2011Mueller Hinton Agar W/4%Nacl and Oxacillin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gibco Laboratories Life Technologies, Inc. · JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Cleared on Oct 9, 1986 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 1986
- Review
- 9 days
- Class
- Class II
- Product code
- JTZ
- Recalls
- 1
- Predicates
- 0
17 later devices descend from it, 5 citing it directly.
- This deviceK863821 Mueller Hinton Agar W/4%Nacl and OxacillinGibco Laboratories Life Technologies, Inc. · 1986
- Descendant · cites it directly · 12 of its ownK042812 Bblchromagar MrsaBecton, Dickinson & CO · 2004
- Descendant · cites it directly · 9 of its ownK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- Descendant · 2 generations on · 4 of its ownK070361 MrsaselectBio-Rad · 2007
- Descendant · cites it directly · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · 3 generations on · 3 of its ownK081212 Mrsaselect - Extended IncubationBio-Rad · 2008 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K042812Bblchromagar MrsaBecton, Dickinson & CO · 2004 · cites it directly12descendants
- K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007 · cites it directly9descendants
- K070361MrsaselectBio-Rad · 2007 · 2 generations on4descendants
- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · cites it directly3descendants
- K081212Mrsaselect - Extended IncubationBio-Rad · 2008 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863821 | Mueller Hinton Agar W/4%Nacl and Oxacillin | Gibco Laboratories Life Technologies, Inc. | 1986 | — |
| +1 | K042812 | Bblchromagar Mrsa | Becton, Dickinson & CO | 2004 | — |
| +1 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| +2 | K070361 | Mrsaselect | Bio-Rad | 2007 | — |
| +1 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| +3 | K081212 | Mrsaselect - Extended Incubation | Bio-Rad | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (17)
See all 175 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 |
|---|---|---|---|---|
| Apr 20, 2011 | Not classified | Z-2608-2011 | Nonconforming Material/Component | Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042812 (Becton, Dickinson & CO, 2004) has gone furthest, with 12 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/K863821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K863821: Mueller Hinton Agar W/4%Nacl and Oxacillin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863821
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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