510(k) · Cleared
Recalled · Class III · 2014Etest Ceftaroline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Oct 12, 2012 as substantially equivalent to K102668 (Biomerieux, 2010) after a 193-day review. Its family tree reaches back 1 generation to 2010. 11 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 12, 2012
- Review
- 193 days
- Class
- Class II
- Product code
- JWY
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102668 (2010). 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK102668 Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLBiomerieux · 2010 · Recalled
- This deviceK121002 Etest CeftarolinebioMerieux, Inc. · 2012
- Descendant · cites it directly · 10 of its ownK151873 Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A. · 2015
- Descendant · 2 generations on · 5 of its ownK180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A. · 2018
- Descendant · 2 generations on · 3 of its ownK170670 Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019 · Recalled
- Descendant · 3 generations on · 2 of its ownK172150 Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)bioMerieux, Inc. · 2017 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K151873Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A. · 2015 · cites it directly10descendants
- K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A. · 2018 · 2 generations on5descendants
- K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc. · 2017 · 2 generations on3descendants
- K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019 · 3 generations on2descendants
- K172150Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)bioMerieux, Inc. · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102668 | Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML | Biomerieux | 2010 | 2 |
| 0 (this device) | K121002 | Etest Ceftaroline | bioMerieux, Inc. | 2012 | — |
| +1 | K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | Biomerieux S.A. | 2015 | — |
| +2 | K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | Biomerieux S.A. | 2018 | — |
| +2 | K170670 | Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) | bioMerieux, Inc. | 2017 | 1 |
| +3 | K192050 | ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) | Biomerieux S.A. | 2019 | 1 |
| +3 | K172150 | Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) | bioMerieux, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K102668 | Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLSummary page 1…uct Code - JWY Common Name: Antimicrobial susceptibility test C. Predicate Device: Etest® Tobramycin (K1 02668) D. 510(k) Summary: Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidio… | 2010 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | 2015 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2014 | Class III | Z-0233-2015 | Labeling Change Control | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. |
| Oct 16, 2014 | Class III | Z-0230-2015 | Labeling Change Control | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. |
| Oct 16, 2014 | Class III | Z-0234-2015 | Labeling Change Control | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. |
| Oct 16, 2014 | Class III | Z-0231-2015 | Labeling Change Control | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. |
| Oct 16, 2014 | Class III | Z-0232-2015 | Labeling Change Control | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K151873 (Biomerieux S.A., 2015) has gone furthest, with 10 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. 2012, 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 quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N.gonorrhoeae, S. pneumnoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory…
Read the full statement (138 words)
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N.gonorrhoeae, S. pneumnoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in pglmL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.
This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 - 32 pg/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent.
Active in vitro and in clinical infections
Skin Infections
Staphylococdus aureus (including methicillin-susceptible and -resistant isolates)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121002: Etest Ceftaroline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121002
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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