Product code JWY: 510(k) clearances and predicates

Product code JWY covers ETEST Gepotidacin (GEP) (0.016-256 µg/mL). FDA lists 441 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

441 clearances on file under product code JWY. Counts by year:

Year	Clearances
2022	0
2023	7
2024	6
2025	14
2026 so far	2

Recent clearances

Newest JWY clearances in the FDA index, with applicant and decision date:

• K260447, ETEST Gepotidacin (GEP) (0.016-256 µg/mL), applicant bioMérieux SA, decided 2026-04-21. FDA record
• K260696, MTS Gepotidacin 0.016-256 µg/mL, applicant Liofilchem s.r.l., decided 2026-04-17. FDA record
• K252114, MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL, applicant Liofilchem s.r.l., decided 2025-10-02. FDA record
• K252062, The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL, applicant Thermo Fisher Scientific, decided 2025-09-25. FDA record
• K250575, The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL, applicant Thermo Fisher Scientific, decided 2025-09-05. FDA record
• K252014, The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL, applicant Thermo Fisher Scientific, decided 2025-08-28. FDA record
• K251580, MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD), applicant Liofilchem s.r.l., decided 2025-08-20. FDA record
• K250990, The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL, applicant Thermo Fisher Scientific, decided 2025-06-30. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include MTS Gepotidacin 0.016-256 µg/mL, MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL. Watch new JWY clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code JWY?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JWY clearances include ETEST Gepotidacin (GEP) (0.016-256 µg/mL).

How many 510(k) clearances use product code JWY?

441 at the time this page was generated, from openFDA records.

How do I find a predicate device under JWY?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new JWY clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.