FDA product code SFO: Electrode Measurement, Drain Effluent Ph
SFO is the FDA product code for electrode measurement, drain effluent ph. It is a Class II device, regulated under 21 CFR 862.1120 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under SFO, 1 in the last five years. The average 510(k) review took 241 days (median 241); 241 days on average over the last three years.
Definition
Measurement of drain effluent pH
Classification
| Field | Value |
|---|---|
| Device name | Electrode Measurement, Drain Effluent Ph |
| Device class | Class II |
| Regulation | 21 CFR 862.1120 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for SFO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 241 |
Compare with all 510(k) review times · Search every SFO clearance
Top SFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nerv Technology Inc. (D.B.A.) Fluidai Medical | 1 | 2025-08-21 |
Most recent SFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243965 | Nerv Technology Inc. (D.B.A.) Fluidai Medical | Origin | 2025-08-21 | 241 |
Recalls for SFO devices
openFDA lists no recalls for product code SFO.
Frequently asked questions
What is FDA product code SFO?
SFO is the FDA product code for electrode measurement, drain effluent ph. It is a Class II device, regulated under 21 CFR 862.1120 and reviewed by the Clinical Chemistry panel.
What device class is SFO?
Class II, regulation 21 CFR 862.1120. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFO?
Across 1 cleared submissions the average was 241 days from receipt to decision (median 241).
Which companies have the most SFO clearances?
Nerv Technology Inc. (D.B.A.) Fluidai Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFO
- Run a recall and safety report across every SFO manufacturer
- Watch product code SFO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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