510(k) · Cleared
ClearedETEST Delafloxacin (DFX) (0.002-32 µg/mL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux S.A. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Nov 26, 2019 as substantially equivalent to K180936 (Biomerieux S.A., 2018) after a 60-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Nov 26, 2019
- Review
- 60 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K102668 (2010). No later device cites it as a predicate yet.
- Root · 4 generations backK102668 Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLBiomerieux · 2010 · Recalled
- 3 generations backK121002 Etest CeftarolinebioMerieux, Inc. · 2012 · Recalled
- 2 generations backK151873 Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A. · 2015
- 1 generation backK180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A. · 2018
- This deviceK192738 ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K102668 | Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML | Biomerieux | 2010 | 2 |
| −3 | K121002 | Etest Ceftaroline | bioMerieux, Inc. | 2012 | 5 |
| −2 | K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | Biomerieux S.A. | 2015 | — |
| −1 | K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | Biomerieux S.A. | 2018 | — |
| 0 (this device) | K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | Biomerieux S.A. | 2019 | — |
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 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? (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 |
|---|---|---|---|
| * | K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL)Summary page 3…n Name(s): ETEST® Delafloxacin; ETEST® DFX C. Predicate Device: ETEST® Telavancin (TLA) (0.002 – 32 μg/mL) (K180936) １ D. Device Descript… | 2018 |
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 9 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K180936.
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. 2019, 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 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. Delafloxacin has been shown to be…
Read the full statement (122 words)
ETEST® is a manual, quantitative technique for 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.
Delafloxacin has been shown to be active against the aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® DFX can be used to determine the MIC of Delafloxacin against the following microorganisms:
Active both in vitro and in clinical infections:
Gram-positive bacteria:
• Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains)
• Staphylococcus haemolyticus
• Staphylococcus lugdunensis
• Enterococcus faecalis
Gram-negative bacteria:
• Pseudomonas aeruginosa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192738: ETEST Delafloxacin (DFX) (0.002-32 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/K192738
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026