510(k) Report

510(k) · Cleared

Cleared

ETEST Telavancin (TLA) (0.002-32 ug/mL)

K180936510(k) TraditionalCleared Jul 3, 201884-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 Jul 3, 2018 as substantially equivalent to K151873 (Biomerieux S.A., 2015) after an 84-day review. Its family tree reaches back 3 generations to 2010. 5 later devices descend from it.

Decided
Jul 3, 2018
Review
84 days
Class
Class II
Product code
JWY
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K102668 (2010). 5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant clearedK102668 · Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML · Biomerieux · 2010 · recalledK121002 · Etest Ceftaroline · bioMerieux, Inc. · 2012 · recalledK151873 · Etest Ceftaroline (0.002 - 32ug/ml) · Biomerieux S.A. · 20152010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K151873 · Etest Ceftaroline (0.002 - 32ug/ml) · Biomerieux S.A. · 2015K121002 · Etest Ceftaroline · bioMerieux, Inc. · 2012 · recalledK102668 · Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML · Biomerieux · 2010 · recalled0
  1. Root · 3 generations backK102668 Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLBiomerieux · 2010 · Recalled
  2. 2 generations backK121002 Etest CeftarolinebioMerieux, Inc. · 2012 · Recalled
  3. 1 generation backK151873 Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A. · 2015
  4. This deviceK180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A. · 2018
  5. Descendant · cites it directly · 2 of its ownK192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK210757 ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A. · 2021
  7. Descendant · 3 generations on · 0 of its ownK260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 2026
  8. Descendant · cites it directly · 0 of its ownK200512 ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA · 2020
  9. Descendant · cites it directly · 0 of its ownK192738 ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A. · 2019

Most influential descendants

Showing 5 of 5 · See all
  • K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 2019 · cites it directly2descendants
  • K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A. · 2021 · 2 generations on1descendant
  • K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 2026 · 3 generations on0descendants
  • K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA · 2020 · cites it directly0descendants
  • K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K102668Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLBiomerieux20102
−2K121002Etest CeftarolinebioMerieux, Inc.20125
−1K151873Etest Ceftaroline (0.002 - 32ug/ml)Biomerieux S.A.2015—
0 (this device)K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)Biomerieux S.A.2018—
+1K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A.20191
+2K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A.2021—
+3K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA2026—
+1K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA2020—
+1K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202010
202110
202610
FIG. 1 — Lineage of K180936, 2010–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K151873Etest Ceftaroline (0.002 - 32ug/ml)
Summary page 4
…ETEST® Telavancin; ETEST® TLA C. Predicate Device: ETEST® Ceftaroline (CPT) (0.002-32 μg/mL) (K151873) D. Device Description: ETEST® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in…
Biomerieux S.A.2015—

Also cleared against K151873: 1 other device →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A.20192
K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)Biomérieux SA20200
K192738ETEST Delafloxacin (DFX) (0.002-32 µg/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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K192050 (Biomerieux S.A., 2019) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K151873.

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. 2018, 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—

What is it indicated for?

ETEST® is a quantitative technique for determination of antimicrobial susceptibility of 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 and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory…

Read the full statement (116 words)

ETEST® is a quantitative technique for determination of antimicrobial susceptibility of 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 and 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 media using overnight incubation.

Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.

Active both in vitro and in clinical infections:

Staphylococcus aureus (including methicillin resistant isolates)

Enterococcus faecalis (vancomycin susceptible isolates only)

Indications for use as stated in the FDA summary.

Also cleared against K151873

1 other device cites the same predicate.

  • K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc. · 20171 recall

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/K180936 · printed Nov 4, 2026

Cite this page

510(k) Report. “K180936: ETEST Telavancin (TLA) (0.002-32 ug/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180936

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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