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

FDA 510(k)

LMNT O2

K-Number: K250125 · 2025-03-24

ApplicantXplr , Ltd.
Decision Date2025-03-24
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LMNT O2 is a medical device manufactured by Xplr , Ltd.. It received FDA 510(k) clearance on 2025-03-24 under approval number K250125. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LMNT O2?

LMNT O2 is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by Xplr , Ltd.. The 510(k) number is K250125.

When was LMNT O2 approved by the FDA?

LMNT O2 received FDA 510(k) clearance on 2025-03-24, under approval number K250125.

What company makes LMNT O2?

LMNT O2 is manufactured by Xplr , Ltd..

What is the FDA product code for LMNT O2?

The FDA product code for LMNT O2 is OHS.

Related Devices (Code: OHS)

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.