510(k) · Cleared
Recalled · Class II · 2015Oxoid Antimicrobial Susceptibility Discs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxoid U.S.A., Inc. · JTN Susceptibility Test Discs, Antimicrobial
Cleared on Mar 4, 1986 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 6 times.
- Decided
- Mar 4, 1986
- Review
- 48 days
- Class
- Class II
- Product code
- JTN
- Recalls
- 6
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 JTN? 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 JTN device
- #1 K230651 BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)score 5.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2015 | Class II | Z-0443-2016 | Nonconforming Material/Component | Antibiotic concentration may be insufficient which may result in incorrect test results. |
| Feb 18, 2014 | Class II | Z-1246-2014 | Process control | Some of the discs may not be impregnated with the antibiotic. |
| Apr 9, 2013 | Class II | Z-0794-2014 | Process design | Cartridges may contain individual discs which were not impregnated with antibiotic. |
| Mar 25, 2013 | Class III | Z-2081-2013 | Unknown/Undetermined by firm | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. |
| Nov 21, 2012 | Class III | Z-0528-2014 | Mixed-up of materials/components | Boxes labeled as CIP5 may contain cartridges of AMP5. |
| Aug 21, 2012 | Class II | Z-0808-2013 | Nonconforming Material/Component | The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JTN devicesJTN Susceptibility Test Discs, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JTN
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JTN
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JTN
31in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTN
7in 2025
MAUDE reports naming product code JTN, 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 | 1 | — | 1 | 2 |
| 2008 | 4 | 44 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 15 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 3 | 0 |
| 2013 | 0 | — | 5 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 56 | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 33 | 0 | 0 |
| 2018 | 3 | 27 | 0 | 0 |
| 2019 | 3 | 23 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 4 | 67 | 0 | 4 |
| 2024 | 2 | — | 31 | 5 |
| 2025 | 7 | 87 | 0 | 7 |
| 2026 | 4 | 56 | 1 | — |
https://510kreport.com/device/K860153 · printed Nov 4, 2026
Cite this page
510(k) Report. “K860153: Oxoid Antimicrobial Susceptibility Discs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860153
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026