FDA product code NSB: Patient Personal Hygiene Kit
NSB is the FDA product code for patient personal hygiene kit. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the General Hospital panel. Devices under NSB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 16 recalls for NSB devices, 15 initiated in the last five years.
Definition
This device contains items given to an individual during their hospital stay.
Classification
| Field | Value |
|---|---|
| Device name | Patient Personal Hygiene Kit |
| Device class | Class I |
| Regulation | 21 CFR 872.6855 |
| Review panel | HO — General Hospital |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NSB devices
16 product recalls in 16 recall events; 15 initiated in the last five years and 15 still open. Most recent: 2026-07-20.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code NSB?
NSB is the FDA product code for patient personal hygiene kit. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the General Hospital panel.
What device class is NSB?
Class I, regulation 21 CFR 872.6855. Typical premarket route: 510(k) exempt.
Have NSB devices been recalled?
Yes: 16 product recalls across 16 recall events; the most recent began 2026-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code NSB
- Run a recall and safety report across every NSB manufacturer
- Watch product code NSB 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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