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)

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

K-Number: K260931 · 2026-04-14

Decision Date2026-04-14
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) is the device name listed in this FDA 510(k) record. The listed applicant is Unimed Medical Supplies, Inc.. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K260931. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)?

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Unimed Medical Supplies, Inc.. The 510(k) number is K260931.

When did Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) receive FDA 510(k) clearance?

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) received FDA 510(k) clearance on 2026-04-14, under 510(k) number K260931.

Who is the listed applicant for Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)?

The FDA 510(k) record lists Unimed Medical Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)?

The FDA product code for Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) is DQA.

Other records listing Unimed Medical Supplies, Inc. 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.

View all 13 devices →

Related Devices (Code: DQA)

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.