FDA product code NZU: Collector, Urine, Powered, Non Indwelling Catheter
NZU is the FDA product code for collector, urine, powered, non indwelling catheter. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under NZU. The average 510(k) review took 77 days (median 77). FDA has posted 1 recall for NZU devices, 1 initiated in the last five years.
Definition
For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.
Classification
| Field | Value |
|---|---|
| Device name | Collector, Urine, Powered, Non Indwelling Catheter |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every NZU clearance
Top NZU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Preferred Medical Devices, Inc. | 1 | 2006-10-05 |
Most recent NZU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062061 | Preferred Medical Devices, Inc. | URASSIST | 2006-10-05 | 77 |
Recalls for NZU devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-23.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code NZU?
NZU is the FDA product code for collector, urine, powered, non indwelling catheter. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is NZU?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NZU?
Across 1 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most NZU clearances?
Preferred Medical Devices, Inc. (1).
Have NZU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-10-23.
Next steps
- Run an FDA pathway report with predicate devices for product code NZU
- Run a recall and safety report across every NZU manufacturer
- Watch product code NZU 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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