FDA product code KQX: Goniometer, Ac-Powered
KQX is the FDA product code for goniometer, ac-powered. It is a Class I device, regulated under 21 CFR 888.1500 and reviewed by the Neurology panel. FDA has cleared 33 510(k) submissions under KQX, from 27 different applicants. The average 510(k) review took 136 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Goniometer, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 888.1500 |
| Review panel | NE — Neurology |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KQX clearance
Top KQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 3 | 1992-08-10 |
| Nk Biotechnical Engineering Co. | 3 | 1991-12-09 |
| J-Tech, Inc. | 2 | 1995-10-30 |
| Greenleaf Medical Systems, Inc. | 2 | 1995-05-15 |
| Orthoscan , Ltd. | 1 | 2001-08-28 |
22 more applicants have KQX clearances. See the full list in Caduvo.
Most recent KQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011827 | Orthoscan , Ltd. | ORTELIUS 800 | 2001-08-28 | 77 |
| K971079 | Interlogics, Inc. | INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE | 1997-07-09 | 106 |
| K962377 | Skill Technologies, Inc. | 3D-SPINE | 1996-09-03 | 75 |
| K961212 | Fasstech | SPINAL TOUCH | 1996-06-12 | 76 |
| K954647 | J-Tech, Inc. | INCLINOMETER | 1995-10-30 | 20 |
Recalls for KQX devices
openFDA lists no recalls for product code KQX.
Frequently asked questions
What is FDA product code KQX?
KQX is the FDA product code for goniometer, ac-powered. It is a Class I device, regulated under 21 CFR 888.1500 and reviewed by the Neurology panel.
What device class is KQX?
Class I, regulation 21 CFR 888.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQX?
Across 33 cleared submissions the average was 136 days from receipt to decision (median 96).
Which companies have the most KQX clearances?
Orthopedic Systems, Inc. (3); Nk Biotechnical Engineering Co. (3); J-Tech, Inc. (2); Greenleaf Medical Systems, Inc. (2); Orthoscan , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQX
- Run a recall and safety report across every KQX manufacturer
- Watch product code KQX 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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