FDA product code NXQ: Reminder, Medication
NXQ is the FDA product code for reminder, medication. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under NXQ, from 2 different applicants. The average 510(k) review took 80 days (median 80). FDA has posted 1 recall for NXQ devices.
Definition
A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules. The device may incorporate wireless communication.
Classification
| Field | Value |
|---|---|
| Device name | Reminder, 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 NXQ clearance
Top NXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Senticare, Inc. | 1 | 2011-01-28 |
| Vocel | 1 | 2006-03-29 |
Most recent NXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K103009 | Senticare, Inc. | SENTICARE PILLSTATION | 2011-01-28 | 108 |
| K060298 | Vocel | PILL PHONE | 2006-03-29 | 51 |
Recalls for NXQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-08-02.
Frequently asked questions
What is FDA product code NXQ?
NXQ is the FDA product code for reminder, medication. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel.
What device class is NXQ?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXQ?
Across 2 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most NXQ clearances?
Senticare, Inc. (1); Vocel (1).
Have NXQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NXQ
- Run a recall and safety report across every NXQ manufacturer
- Watch product code NXQ 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