FDA product code NNI: Container, Specimen, Non-Sterile
NNI is the FDA product code for container, specimen, non-sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the General Hospital panel. Devices under NNI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for NNI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Container, Specimen, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 864.3250 |
| Review panel | HO — General Hospital |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNI devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2026-03-09.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NNI?
NNI is the FDA product code for container, specimen, non-sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the General Hospital panel.
What device class is NNI?
Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.
Have NNI devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2026-03-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NNI
- Run a recall and safety report across every NNI manufacturer
- Watch product code NNI 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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