510(k) · Cleared
Recalled · Class II · 2022ETEST Eravacycline (ERV) (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 Sep 27, 2019 as substantially equivalent to K180936 (Biomerieux S.A., 2018) after a 58-day review. Its family tree reaches back 4 generations to 2010. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 27, 2019
- Review
- 58 days
- Class
- Class II
- Product code
- JWY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K102668 (2010). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019
- Descendant · cites it directly · 1 of its ownK210757 ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 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 |
|---|---|---|---|---|---|
| −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) | K192050 | ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) | Biomerieux S.A. | 2019 | — |
| +1 | K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Biomerieux S.A. | 2021 | — |
| +2 | K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
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 4…TEST® Eravacycline; ETEST® ERV C. Predicate Device: ETEST® Telavancin (TLA) (0.002-32 μg/mL) (K180936) bioMerieux SA • 376 chemin de l’Orme • 69280 Marcy-l’Etoile • Tel: +33(0)4 78 87 20 00… | 2018 |
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 |
|---|---|---|---|
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | 2021 | 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-0851-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
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.
- Of its descendants, K210757 (Biomerieux S.A., 2021) has gone furthest, with 1 descendant of its own.
- 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, i ) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation. Eravacycline has been shown to be…
Read the full statement (134 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, i ) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation.
Eravacycline has been shown to be active against most isolates of the microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® ERV can be used to determine the MIC of Eravacycline against the following microorganisms:
Active both in vitro and in clinical infections:
Gram-negative:
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Gram-positive:
Enterococcus faecalis
Enterococcus faecium
In vitro data are available for the following microorganisms, but clinical significance is unknown:
Citrobacter koseri
Klebsiella aerogenes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192050: ETEST Eravacycline (ERV) (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/K192050
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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