510(k) · Cleared
ClearedETEST Gepotidacin (GEP) (0.016-256 µg/mL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMérieux SA · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Apr 21, 2026 as substantially equivalent to K210757 (Biomerieux S.A., 2021) after a 69-day review. Its family tree reaches back 6 generations to 2010.
- Decided
- Apr 21, 2026
- Review
- 69 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K102668 (2010). No later device cites it as a predicate yet.
- Root · 6 generations backK102668 Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLBiomerieux · 2010 · Recalled
- 5 generations backK121002 Etest CeftarolinebioMerieux, Inc. · 2012 · Recalled
- 4 generations backK151873 Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A. · 2015
- 3 generations backK180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A. · 2018
- 2 generations backK192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019 · Recalled
- 1 generation backK210757 ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A. · 2021
- This deviceK260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K102668 | Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML | Biomerieux | 2010 | 2 |
| −5 | K121002 | Etest Ceftaroline | bioMerieux, Inc. | 2012 | 5 |
| −4 | K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | Biomerieux S.A. | 2015 | — |
| −3 | K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | Biomerieux S.A. | 2018 | — |
| −2 | K192050 | ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) | Biomerieux S.A. | 2019 | 1 |
| −1 | K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Biomerieux S.A. | 2021 | — |
| 0 (this device) | K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K260696 MTS Gepotidacin 0.016-256 µg/mLscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL)Summary page 5…Product Code: JWY Common Name(s): ETEST® Gepotidacin (GEP) C. Predicate Device: ETEST® Fosfomycin (FO) (0.032-512 µg/mL) (K210757) 1/7 D. Device Desc… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
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. 2026, this device’s year, is highlighted.
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 | — |
What is it indicated for?
ETEST is a manual, quantitative technique for the determination of antimicrobial susceptibility of non‑fastidious Gram‑negative and Gram‑positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Testing with ETEST Gepotidacin…
Read the full statement (106 words)
ETEST is a manual, quantitative technique for the determination of antimicrobial susceptibility of non‑fastidious Gram‑negative and Gram‑positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.
Testing with ETEST Gepotidacin (GEP) (0.016-256 μg/mL) is indicated for Enterobacterales, Staphylococcus saprophyticus, Enterococcus faecalis and Neisseria gonorrhoeae, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
ETEST Gepotidacin (GEP) (0.016-256 μg/mL) demonstrated acceptable performance with the following microorganisms:
• Escherichia coli
• Staphylococcus saprophyticus
• Enterococcus faecalis
• Neisseria gonorrhoeae
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260447: ETEST Gepotidacin (GEP) (0.016-256 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260447
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026