510(k) · Cleared
ClearedMTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liofilchem s.r.l. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Aug 20, 2025 as substantially equivalent to K153687 (Liofilchem s.r.l., 2016) after an 89-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Aug 20, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K153687 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK153687 Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mLLiofilchem s.r.l. · 2016
- This deviceK251580 MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | Liofilchem s.r.l. | 2016 | — |
| 0 (this device) | K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | 2025 | — |
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 |
|---|---|---|---|
| * | K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mLSummary page 5…ulatory Class: Class II Product Code: JWY – Manual Antimicrobial Test Systems III. PREDICATE DEVICES Liofilchem MTS, vancomycin K153687 These predicate products have not been subject to a design-related recall. No reference devices were used in this… | 2016 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K153687.
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. 2025, 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?
The MTS (MIC Test Strip) Sulbactam-Durlobactam 0.004/4-64/4 pug/ml is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in pg/ml of antimicrobial agents against bacteria as tested on agar media using overnight…
Read the full statement (125 words)
The MTS (MIC Test Strip) Sulbactam-Durlobactam 0.004/4-64/4 pug/ml is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in pg/ml of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Sulbactam-Durlobactam at concentrations of 0.004/4-64/4 ng/ml should be interpreted at 16-20 hours of incubation.
Testing with MTS Sulbactam-Durlobactam at concentrations of 0.004/4-64/4 pg/mL is indicated for Acinetobacter baumannii calcoaceticus complex as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
The MTS Sulbactam-Durlobactam 0.004/4-64/4 pg/mL has demonstrated acceptable performance with the following organisms:
Acinetobacter baumannii calcoaceticus complex
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251580: MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251580
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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