FDA product code LQX: Device, Finger-Sucking
LQX is the FDA product code for device, finger-sucking. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under LQX, from 2 different applicants. The average 510(k) review took 96 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Device, Finger-Sucking |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | DE — Dental |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top LQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med ET AL Development | 1 | 1995-03-23 |
| Levolon Company, Inc. | 1 | 1987-02-12 |
Most recent LQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945537 | Med ET AL Development | T-GUARD | 1995-03-23 | 129 |
| K864870 | Levolon Company, Inc. | THUMBSHELPER POWER RING | 1987-02-12 | 62 |
Recalls for LQX devices
openFDA lists no recalls for product code LQX.
Frequently asked questions
What is FDA product code LQX?
LQX is the FDA product code for device, finger-sucking. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Dental panel.
What device class is LQX?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LQX?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most LQX clearances?
Med ET AL Development (1); Levolon Company, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQX
- Run a recall and safety report across every LQX manufacturer
- Watch product code LQX 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.