FDA product code NIH: Disinfectant, Subsystem, Water Purification
NIH is the FDA product code for disinfectant, subsystem, water purification. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NIH. The average 510(k) review took 264 days (median 264).
Definition
Disinfectant intended for reprocessing water purification systems for hemodialysis.
Classification
| Field | Value |
|---|---|
| Device name | Disinfectant, Subsystem, Water Purification |
| Device class | Class II |
| Regulation | 21 CFR 876.5665 |
| Review panel | HO — General Hospital |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NIH clearance
Top NIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medivators, Inc. | 1 | 2014-08-27 |
Most recent NIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133724 | Medivators, Inc. | MINNCARE HD | 2014-08-27 | 264 |
Recalls for NIH devices
openFDA lists no recalls for product code NIH.
Frequently asked questions
What is FDA product code NIH?
NIH is the FDA product code for disinfectant, subsystem, water purification. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the General Hospital panel.
What device class is NIH?
Class II, regulation 21 CFR 876.5665. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NIH?
Across 1 cleared submissions the average was 264 days from receipt to decision (median 264).
Which companies have the most NIH clearances?
Medivators, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NIH
- Run a recall and safety report across every NIH manufacturer
- Watch product code NIH 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times