510(k) · Cleared
ClearedEtest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus SPP. and Anaerobic Bacteria
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ab Biodisk · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Oct 13, 2005 after a 45-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 13, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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.
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 the addition of Tigecycline to the Etest® product range for MIC determination across 0.016-256 µg/mL with Gram positive and Gram negative aerobic bacteria, Streptococcus species other than S. pneumoniae and anaerobic bacteria. Etest® is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas…
Read the full statement (110 words)
This submission is for the addition of Tigecycline to the Etest® product range for MIC determination across 0.016-256 µg/mL with Gram positive and Gram negative aerobic bacteria, Streptococcus species other than S. pneumoniae and anaerobic bacteria.
Etest® is a quantitative technique for the 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. pneumoniae, Streptococcus, Haemophilus species. 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 as tested on agar using overnight incubation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052366: Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus SPP. and Anaerobic Bacteria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052366
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026