510(k) · Cleared
Recalled · Class II · 2022Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Nov 17, 2010 after a 62-day review. The FDA summary names no predicate by number. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 17, 2010
- Review
- 62 days
- Class
- Class II
- Product code
- JWY
- Recalls
- 2
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK102668 Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLBiomerieux · 2010
- Descendant · cites it directly · 11 of its ownK121002 Etest CeftarolinebioMerieux, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 10 of its ownK151873 Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A. · 2015
- Descendant · 3 generations on · 5 of its ownK180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A. · 2018
- Descendant · 3 generations on · 3 of its ownK170670 Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K121002Etest CeftarolinebioMerieux, Inc. · 2012 · cites it directly11descendants
- K151873Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A. · 2015 · 2 generations on10descendants
- K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A. · 2018 · 3 generations on5descendants
- K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc. · 2017 · 3 generations on3descendants
- K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102668 | Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML | Biomerieux | 2010 | — |
| +1 | K121002 | Etest Ceftaroline | bioMerieux, Inc. | 2012 | 5 |
| +2 | 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 | — |
| +3 | K170670 | Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) | bioMerieux, Inc. | 2017 | 1 |
| +4 | K192050 | ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) | Biomerieux S.A. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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?
The FDA summary names no predicate by number.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121002 | Etest Ceftaroline | 2012 | 11 |
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-0830-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Dec 15, 2016 | Class II | Z-1531-2017 | Storage | Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121002 (bioMerieux, Inc., 2012) has gone furthest, with 11 descendants 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. 2010, 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?
This submission is for Etest®Tobramycin for MIC determinations across 0.016-256 ptg/mL and 0.064-1024 Iig/mL with Staphylot-acms aurrus, Enterobaciediaceaeand P. aerztginosa. Etest®1 is a cquantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as En/erobasaerzaceae, IRseudomonaj, Slaphylo toxns and En/erotocats species and fastidious bacteria, such as…
Read the full statement (95 words)
This submission is for Etest®Tobramycin for MIC determinations across 0.016-256 ptg/mL and 0.064-1024 Iig/mL with Staphylot-acms aurrus, Enterobaciediaceaeand P. aerztginosa.
Etest®1 is a cquantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as En/erobasaerzaceae, IRseudomonaj, Slaphylo toxns and En/erotocats species and fastidious bacteria, such as anacrobes, N. ,gonotrhoeae, S. pneunoniae, Sftrp/otoczus and Haernophiluj species. The system comprises a predefined antibiotic gradient which is used to determine the NMinmum Inhibitory Concentration (MIC) in pg/mE of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102668: Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102668
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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