510(k) · Cleared
ClearedOsteoProbe
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 Jun 28, 2022 as substantially equivalent to DEN210013 (Active Life Scientific, Inc., 2021) after a 64-day review. Its family tree reaches back 1 generation to 2021. 1 later device descends from it.
- Decided
- Jun 28, 2022
- Review
- 64 days
- Class
- Class II
- Product code
- QGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210013 (2021). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K250216OsteoProbe (OP-100)Active Life Scientific, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210013 | OsteoProbe | Active Life Scientific, Inc. | 2021 | — |
| 0 (this device) | K221195 | OsteoProbe | Active Life Scientific, Inc. | 2022 | — |
| +1 | K250216 | OsteoProbe (OP-100) | Active Life Scientific, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 K250216 OsteoProbe (OP-100)score 10.3 · 2 generations · 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 |
|---|---|---|---|
| * | DEN210013 | OsteoProbeSummary page 4…21 CFR §888.1600, Bone indentation device Class: II Product Code: QGQ Predicate Devices: OsteoProbe – DEN210013 Indications for Use: The OsteoProbe is indicated for use as a measurement tool to measure bone tissue… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250216 | OsteoProbe (OP-100) | 2025 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K250216 (Active Life Scientific, Inc., 2025) has gone furthest, with 0 descendants 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. 2022, 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/K221195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221195: OsteoProbe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221195
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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