Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Chemfort Female Luer Lock Adaptor

K-Number: K251411 · 2025-08-05

Decision Date2025-08-05
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chemfort Female Luer Lock Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2025-08-05 under 510(k) number K251411. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chemfort Female Luer Lock Adaptor?

Chemfort Female Luer Lock Adaptor is a medical device that received FDA 510(k) clearance on 2025-08-05. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K251411.

When did Chemfort Female Luer Lock Adaptor receive FDA 510(k) clearance?

Chemfort Female Luer Lock Adaptor received FDA 510(k) clearance on 2025-08-05, under 510(k) number K251411.

Who is the listed applicant for Chemfort Female Luer Lock Adaptor?

The FDA 510(k) record lists Simplivia Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chemfort Female Luer Lock Adaptor?

The FDA product code for Chemfort Female Luer Lock Adaptor is ONB.

Other records listing Simplivia Healthcare , Ltd. 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.

Related Devices (Code: ONB)

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.

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.