4DM
K-Number: K260879 · 2026-09-10
ApplicantINVIA, LLC
Decision Date2026-09-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
4DM is the device name listed in this FDA 510(k) record. The listed applicant is INVIA, LLC. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K260879. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 4DM?
4DM is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is INVIA, LLC. The 510(k) number is K260879.
When did 4DM receive FDA 510(k) clearance?
4DM received FDA 510(k) clearance on 2026-09-10, under 510(k) number K260879.
Who is the listed applicant for 4DM?
The FDA 510(k) record lists INVIA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 4DM?
The FDA product code for 4DM is QIH.
Related Devices (Code: QIH)
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
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