Origin™
K-Number: K243965 · 2025-08-21
Decision Date2025-08-21
Product CodeSFO
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Origin™ is the device name listed in this FDA 510(k) record. The listed applicant is Nerv Technology Inc. (D.B.A.) Fluidai Medical. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K243965. The device is classified under product code SFO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Origin™?
Origin™ is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Nerv Technology Inc. (D.B.A.) Fluidai Medical. The 510(k) number is K243965.
When did Origin™ receive FDA 510(k) clearance?
Origin™ received FDA 510(k) clearance on 2025-08-21, under 510(k) number K243965.
Who is the listed applicant for Origin™?
The FDA 510(k) record lists Nerv Technology Inc. (D.B.A.) Fluidai Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Origin™?
The FDA product code for Origin™ is SFO.
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.