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)

KLS Martin Ixos System

K-Number: K254162 · 2026-02-20

Decision Date2026-02-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KLS Martin Ixos System is a medical device manufactured by KLS Martin L.P.. It received FDA 510(k) clearance on 2026-02-20 under approval number K254162. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Ixos System?

KLS Martin Ixos System is a medical device that received FDA 510(k) clearance on 2026-02-20. It is manufactured by KLS Martin L.P.. The 510(k) number is K254162.

When was KLS Martin Ixos System approved by the FDA?

KLS Martin Ixos System received FDA 510(k) clearance on 2026-02-20, under approval number K254162.

What company makes KLS Martin Ixos System?

KLS Martin Ixos System is manufactured by KLS Martin L.P..

What is the FDA product code for KLS Martin Ixos System?

The FDA product code for KLS Martin Ixos System is HRS.

Other Devices by KLS Martin L.P.

View all 11 devices →

Related Devices (Code: HRS)

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.