FDA product code QGQ: Bone Indentation Device
QGQ is the FDA product code for bone indentation device. It is a Class II device, regulated under 21 CFR 888.1600 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under QGQ, 2 in the last five years. The average 510(k) review took 147 days (median 147); 230 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A bone indentation device is a device that measures resistance to indentation in bone.
Classification
| Field | Value |
|---|---|
| Device name | Bone Indentation Device |
| Device class | Class II |
| Regulation | 21 CFR 888.1600 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for QGQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 64 |
| 2025 | 1 | 230 |
Compare with all 510(k) review times · Search every QGQ clearance
Top QGQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Active Life Scientific, Inc. | 2 | 2025-09-11 |
Most recent QGQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250216 | Active Life Scientific, Inc. | OsteoProbe (OP-100) | 2025-09-11 | 230 |
| K221195 | Active Life Scientific, Inc. | OsteoProbe | 2022-06-28 | 64 |
Recalls for QGQ devices
openFDA lists no recalls for product code QGQ.
Frequently asked questions
What is FDA product code QGQ?
QGQ is the FDA product code for bone indentation device. It is a Class II device, regulated under 21 CFR 888.1600 and reviewed by the Orthopedic panel.
What device class is QGQ?
Class II, regulation 21 CFR 888.1600. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGQ?
Across 2 cleared submissions the average was 147 days from receipt to decision (median 147).
Which companies have the most QGQ clearances?
Active Life Scientific, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QGQ
- Run a recall and safety report across every QGQ manufacturer
- Watch product code QGQ 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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