FDA product code MSY: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
MSY is the FDA product code for strip, test, reagent, residuals for dialysate, disinfectant. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 13 510(k) submissions under MSY, 2 in the last five years, from 6 different applicants. The average 510(k) review took 155 days (median 98); 113 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| 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 MSY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 349 |
| 2022 | 1 | 89 |
| 2025 | 1 | 113 |
Compare with all 510(k) review times · Search every MSY clearance
Top MSY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Environmental Test Systems, Inc. | 5 | 2000-07-11 |
| Nelson Environmental Technologies, Inc. | 2 | 2025-04-11 |
| Reprocessing Products Corporation (Rpc) | 2 | 2022-10-18 |
| Reprocessing Products Corp | 2 | 2009-05-08 |
| Serim Research Corp. | 1 | 2008-05-06 |
1 more applicants have MSY clearances. See the full list in Caduvo.
Most recent MSY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243898 | Nelson Environmental Technologies, Inc. | Chlorine Sentinel II | 2025-04-11 | 113 |
| K222167 | Reprocessing Products Corporation (Rpc) | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | 2022-10-18 | 89 |
| K193169 | Nelson Environmental Technologies, Inc. | Nelson Sentinel Series Basic Chlorine Sentinel | 2020-10-29 | 349 |
| K132344 | Reprocessing Products Corporation (Rpc) | E-Z CHECK OZONE TEST STRIPS | 2014-02-25 | 211 |
| K090338 | Reprocessing Products Corp | ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE | 2009-05-08 | 87 |
Recalls for MSY devices
openFDA lists no recalls for product code MSY.
Frequently asked questions
What is FDA product code MSY?
MSY is the FDA product code for strip, test, reagent, residuals for dialysate, disinfectant. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel.
What device class is MSY?
Class II, regulation 21 CFR 876.5665. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSY?
Across 13 cleared submissions the average was 155 days from receipt to decision (median 98).
Which companies have the most MSY clearances?
Environmental Test Systems, Inc. (5); Nelson Environmental Technologies, Inc. (2); Reprocessing Products Corporation (Rpc) (2); Reprocessing Products Corp (2); Serim Research Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MSY
- Run a recall and safety report across every MSY manufacturer
- Watch product code MSY 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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