510(k) Report

510(k) · Cleared

Cleared

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

K183031510(k) TraditionalCleared Jan 11, 201971-day reviewClass II21 CFR 866.1640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomerieux S.A. · JWY Manual Antimicrobial Susceptibility Test Systems

Cleared on Jan 11, 2019 after a 71-day review. The FDA summary names no predicate by number. 3 later devices descend from it.

Decided
Jan 11, 2019
Review
71 days
Class
Class II
Product code
JWY
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2025: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared201620182020202220242026
  1. This deviceK183031 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)Biomerieux S.A. · 2019
  2. Descendant · cites it directly · 0 of its ownK250274 ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A. · 2025
  3. Descendant · cites it directly · 0 of its ownK232395 ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDBiomérieux · 2023
  4. Descendant · cites it directly · 0 of its ownK191953 ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A. · 2019 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A. · 2025 · cites it directly0descendants
  • K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDBiomérieux · 2023 · cites it directly0descendants
  • K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)Biomerieux S.A.2019—
+1K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A.2025—
+1K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDBiomérieux2023—
+1K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A.20192

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202310
202510
FIG. 1 — Lineage of K183031, 2019–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A.20250
K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDBiomérieux20230
K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A.20190

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?

  • Of its descendants, K250274 (Biomerieux S.A., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JWY devices

JWY 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

2008: 62009: 22010: 42011: 42012: 12014: 62015: 92016: 42017: 142018: 122019: 182020: 52021: 52023: 72024: 62025: 142026 (partial year): 2
2007high 18 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWY

106in 2025

2008: 85 days median2010: 73 days median2011: 125 days median2014: 106 days median2015: 90 days median2016: 88 days median2017: 61 days median2018: 51 days median2019: 60 days median2020: 66 days median2021: 266 days median2023: 85 days median2024: 90 days median2025: 106 days median
2007high 266 (2021) · low 51 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWY

31in 2022

2008: 12011: 32014: 52015: 6, 4 Class I2017: 22022: 31, 9 Class I
2007high 31 (2022) · low 0 (2007)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · JWY

1in 2024

2008: 12009: 12014: 42015: 112016: 202017: 92018: 132019: 102020: 202021: 412022: 112023: 92024: 1
2007high 41 (2021) · low 0 (2007)2025

MAUDE reports naming product code JWY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
200868511
20092—01
201047300
2011412530
20121—00
20130—00
2014610654
20159906 (4)11
2016488020
2017146129
20181251013
20191860010
2020566020
20215266041
20220—31 (9)11
202378509
202469001
20251410600
20262—0—

More from Biomerieux S.A.

16 FDA decisions under this applicant name. See the company

  • K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A. · 2025
  • K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A. · 2021
  • K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A. · 2019
  • K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 20191 recall
  • K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A. · 20192 recalls

Recent decisions in JWY

The JWY category page

  • K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 2026
  • K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l. · 2026
  • K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l. · 2025
  • K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of…Thermo Fisher Scientific · 2025
  • K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution…Thermo Fisher Scientific · 2025

https://510kreport.com/device/K183031 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183031: ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 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/K183031

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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