510(k) · Cleared
ClearedOsteoProbe (OP-100)
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
Cleared on Sep 11, 2025 as substantially equivalent to K221195 (Active Life Scientific, Inc., 2022) after a 230-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Sep 11, 2025
- Review
- 230 days
- Class
- Class II
- Product code
- QGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN210013 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) 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 K221195 OsteoProbescore 6.6 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221195 | OsteoProbeSummary page 6…erformance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices: Primary Predicate: OsteoProbe [K221195] Additional Predicate: N/A Performance Testing Summary: Performance testing on cadavers was completed to demonstrate correlation… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QGQ devicesQGQ Bone Indentation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 a measurement tool intended to assess bone tissue resistance to microindentation on the tibia of adults, reported as the Bone Material Strength Index (BMSi). In laboratory studies, BMSi measurements have been shown to correlate with biomechanical properties of bone, including whole-bone strength and fracture toughness. The clinical significance of laboratory-based biomechanical studies is unknown. The device is not intended to diagnose disease, predict fracture risk, or treat any clinical condition. Prescription use only, by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250216: OsteoProbe (OP-100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250216
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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