Cleared Traditional

K243965 - Origin™ (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243965 · Nerv Technology Inc. (D.B.A.) Fluidai Medical · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
241d
Days
Class 2
Risk

K243965 is an FDA 510(k) clearance for the Origin™. Classified as Electrode Measurement, Drain Effluent Ph (product code SFO), Class II - Special Controls.

Submitted by Nerv Technology Inc. (D.B.A.) Fluidai Medical (Kitchener, CA). The FDA issued a Cleared decision on August 21, 2025 after a review of 241 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Nerv Technology Inc. (D.B.A.) Fluidai Medical devices

Submission Details

510(k) Number K243965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2024
Decision Date August 21, 2025
Days to Decision 241 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 88d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SFO Electrode Measurement, Drain Effluent Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
Definition Measurement Of Drain Effluent Ph
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.