FDA product code MNV: Strip, Dialysate Ph Indicator
MNV is the FDA product code for strip, dialysate ph indicator. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under MNV, from 4 different applicants. The average 510(k) review took 335 days (median 297). FDA has posted 1 recall for MNV devices.
Classification
| Field | Value |
|---|---|
| Device name | Strip, Dialysate Ph Indicator |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MNV clearance
Top MNV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mitek Surgical Products, Inc. | 3 | 1995-10-31 |
| Reprocessing Products Corp | 1 | 2011-01-07 |
| Environmental Test Systems, Inc. | 1 | 2003-12-23 |
| Serim Research Corp. | 1 | 1995-02-01 |
Most recent MNV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101750 | Reprocessing Products Corp | RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 | 2011-01-07 | 199 |
| K031267 | Environmental Test Systems, Inc. | STERICHEK BICARB PH REAGENT STRIPS | 2003-12-23 | 246 |
| K936311 | Mitek Surgical Products, Inc. | MITEK MINI ANCHOR | 1995-10-31 | 559 |
| K941599 | Mitek Surgical Products, Inc. | MITEK ABSORBABLE ANCHOR | 1995-10-24 | 571 |
| K944051 | Mitek Surgical Products, Inc. | ABSORBALBE ANCHOR | 1995-08-02 | 348 |
Recalls for MNV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-02-25.
Frequently asked questions
What is FDA product code MNV?
MNV is the FDA product code for strip, dialysate ph indicator. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is MNV?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNV?
Across 6 cleared submissions the average was 335 days from receipt to decision (median 297).
Which companies have the most MNV clearances?
Mitek Surgical Products, Inc. (3); Reprocessing Products Corp (1); Environmental Test Systems, Inc. (1); Serim Research Corp. (1).
Have MNV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MNV
- Run a recall and safety report across every MNV manufacturer
- Watch product code MNV 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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