FDA 510(k)

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)

K-Number: K251580 · 2025-08-20

Decision Date2025-08-20

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K251580. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)?

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K251580.

When did MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) receive FDA 510(k) clearance?

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) received FDA 510(k) clearance on 2025-08-20, under 510(k) number K251580.

Who is the listed applicant for MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)?

The FDA 510(k) record lists Liofilchem s.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)?

The FDA product code for MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) is JWY.

Other records listing Liofilchem s.r.l. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260696MTS Gepotidacin 0.016-256 µg/mL K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL K243202MTS Ceftobiprole 0.002-32 µg/mL K230479ComASP Cefiderocol 0.008-128 K211672MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL K200180MTS Omadacycline 0.002 - 32 ug/mL

View all 35 devices →

Related Devices (Code: JWY)

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher Scientific K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher Scientific K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.