# K243965: Origin™

- Pathway: 510(k) (Traditional)
- Applicant: Nerv Technology Inc. (D.B.A.) Fluidai Medical
- Decided: Aug 21, 2025 after 241 days
- Product code: SFO (Electrode Measurement, Drain Effluent Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ABL835 Flex Analyzer: named in the summary without a submission number

## Indications for use
The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.

Source page: https://510kreport.com/device/K243965
Methodology: https://510kreport.com/methodology