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FDA 510(k)

INTEGRE LIO

K-Number: K251507 · 2026-02-06

Decision Date2026-02-06
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTEGRE LIO is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251507. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRE LIO?

INTEGRE LIO is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Quantel Medical. The 510(k) number is K251507.

When did INTEGRE LIO receive FDA 510(k) clearance?

INTEGRE LIO received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251507.

Who is the listed applicant for INTEGRE LIO?

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

What is the FDA product code for INTEGRE LIO?

The FDA product code for INTEGRE LIO is HQF.

Other records listing Quantel Medical 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 9 devices →

Related Devices (Code: HQF)

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.