K243965 is an FDA 510(k) clearance for the Origin™. This device is classified as a Electrode Measurement, Drain Effluent Ph (Class II - Special Controls, product code SFO).
Submitted by Nerv Technology Inc. (D.B.A.) Fluidai Medical (Kitchener, CA). The FDA issued a Cleared decision on August 21, 2025, 241 days after receiving the submission on December 23, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120. Measurement Of Drain Effluent Ph.
| 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 |
| Product Code | SFO - Electrode Measurement, Drain Effluent Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |
| Definition | Measurement Of Drain Effluent Ph |