De Novo · Granted
GrantedOsteoProbe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Active Life Scientific, Inc. · QGQ Bone Indentation Device
Granted on Aug 19, 2021 as a new device type through De Novo after a 142-day review. 2 later devices descend from it.
- Decided
- Aug 19, 2021
- Review
- 142 days
- Class
- Class II
- Product code
- QGQ
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210013 | OsteoProbe | Active Life Scientific, Inc. | 2021 | — |
| +1 | K221195 | OsteoProbe | Active Life Scientific, Inc. | 2022 | — |
| +2 | K250216 | OsteoProbe (OP-100) | Active Life Scientific, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QGQ device
- #1 K250216 OsteoProbe (OP-100)score 10.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221195 | OsteoProbe | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K221195 (Active Life Scientific, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QGQ devicesQGQ Bone Indentation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QGQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QGQ
Too few QGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QGQ
No recall names QGQ since 2007.
Adverse event reports per year · QGQ
No MAUDE report names QGQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OsteoProbe is indicated for use as a measurement tool to measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. The device is not intended to diagnose or treat any clinical condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210013 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210013: OsteoProbe.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210013
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026