510(k) · Cleared
Recalled · Class II · 2022The E Test, Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ab Biodisk · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Sep 25, 1991 after a 51-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 25, 1991
- Review
- 51 days
- Class
- Class II
- Product code
- JWY
- Recalls
- 6
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK913459 The E Test, ModificationAb Biodisk · 1991
- Descendant · cites it directly · 1 of its ownK963036 Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse BloodBecton Dickinson Microbiology Systems · 1996
- Descendant · 2 generations on · 0 of its ownK262163 BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller…Becton Dickinson and Company · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913459 | The E Test, Modification | Ab Biodisk | 1991 | — |
| +1 | K963036 | Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood | Becton Dickinson Microbiology Systems | 1996 | — |
| +2 | K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson and Company | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2026 | 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 JWY? 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 JWY device
- #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963036 | Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood | 1996 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2022 | Class II | Z-0819-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Class II | Z-0823-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Apr 13, 2017 | Class II | Z-0264-2018 | Under Investigation by firm | QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results. |
| Apr 13, 2017 | Class II | Z-0265-2018 | Under Investigation by firm | QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results. |
| Dec 15, 2016 | Class II | Z-1522-2017 | Storage | Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. |
| Dec 15, 2016 | Class II | Z-1530-2017 | Storage | Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K963036 (Becton Dickinson Microbiology Systems, 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JWY devicesJWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWY
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWY
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWY
31in 2022
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · JWY
1in 2024
MAUDE reports naming product code JWY, 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 | 6 | 85 | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 4 | 73 | 0 | 0 |
| 2011 | 4 | 125 | 3 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 6 | 106 | 5 | 4 |
| 2015 | 9 | 90 | 6 (4) | 11 |
| 2016 | 4 | 88 | 0 | 20 |
| 2017 | 14 | 61 | 2 | 9 |
| 2018 | 12 | 51 | 0 | 13 |
| 2019 | 18 | 60 | 0 | 10 |
| 2020 | 5 | 66 | 0 | 20 |
| 2021 | 5 | 266 | 0 | 41 |
| 2022 | 0 | — | 31 (9) | 11 |
| 2023 | 7 | 85 | 0 | 9 |
| 2024 | 6 | 90 | 0 | 1 |
| 2025 | 14 | 106 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K913459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913459: The E Test, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913459
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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