FDA product code NXB: Dispenser, Solid Medication
NXB is the FDA product code for dispenser, solid medication. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under NXB, from 3 different applicants. The average 510(k) review took 169 days (median 166). FDA has posted 1 recall for NXB devices.
Definition
A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.
Classification
| Field | Value |
|---|---|
| Device name | Dispenser, Solid Medication |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | HO — General Hospital |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every NXB clearance
Top NXB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Garan Scientific, Inc. | 1 | 1995-04-10 |
| Dynex Trading Co. | 1 | 1988-12-14 |
| Apothecary Products, Inc. | 1 | 1984-02-04 |
Most recent NXB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944481 | Garan Scientific, Inc. | THE HEART PROTECTOR | 1995-04-10 | 209 |
| K882731 | Dynex Trading Co. | TAB PAK | 1988-12-14 | 166 |
| K833311 | Apothecary Products, Inc. | NITROGLYCERINE CONTAINER | 1984-02-04 | 131 |
Recalls for NXB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-07-02.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code NXB?
NXB is the FDA product code for dispenser, solid medication. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel.
What device class is NXB?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXB?
Across 3 cleared submissions the average was 169 days from receipt to decision (median 166).
Which companies have the most NXB clearances?
Garan Scientific, Inc. (1); Dynex Trading Co. (1); Apothecary Products, Inc. (1).
Have NXB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-07-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NXB
- Run a recall and safety report across every NXB manufacturer
- Watch product code NXB 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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