FDA product code PSX: Chlorine Meter
PSX is the FDA product code for chlorine meter. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under PSX. The average 510(k) review took 205 days (median 205).
Definition
These devices are intended to measure chlorine levels in water.
Classification
| Field | Value |
|---|---|
| Device name | Chlorine Meter |
| Device class | Class II |
| Regulation | 21 CFR 876.5665 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for PSX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 205 |
Compare with all 510(k) review times · Search every PSX clearance
Top PSX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hach Company | 1 | 2017-03-30 |
Most recent PSX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162471 | Hach Company | Hach CM130 Chlorine Monitoring System | 2017-03-30 | 205 |
Recalls for PSX devices
openFDA lists no recalls for product code PSX.
Frequently asked questions
What is FDA product code PSX?
PSX is the FDA product code for chlorine meter. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel.
What device class is PSX?
Class II, regulation 21 CFR 876.5665. Typical premarket route: 510(k).
How long does a 510(k) take for product code PSX?
Across 1 cleared submissions the average was 205 days from receipt to decision (median 205).
Which companies have the most PSX clearances?
Hach Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PSX
- Run a recall and safety report across every PSX manufacturer
- Watch product code PSX 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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