FDA product code LRI: Ph Meter For Dialysis Hydrogen Ion Concentration
LRI is the FDA product code for ph meter for dialysis hydrogen ion concentration. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under LRI. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Ph Meter For Dialysis Hydrogen Ion Concentration |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every LRI clearance
Top LRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mesa Medical, Inc. | 1 | 1987-03-24 |
Most recent LRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870811 | Mesa Medical, Inc. | MODEL 102 PH METER | 1987-03-24 | 21 |
Recalls for LRI devices
openFDA lists no recalls for product code LRI.
Frequently asked questions
What is FDA product code LRI?
LRI is the FDA product code for ph meter for dialysis hydrogen ion concentration. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is LRI?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRI?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most LRI clearances?
Mesa Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LRI
- Run a recall and safety report across every LRI manufacturer
- Watch product code LRI 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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