# K221195: OsteoProbe

- Pathway: 510(k) (Special)
- Applicant: Active Life Scientific, Inc.
- Decided: Jun 28, 2022 after 64 days
- Product code: QGQ (Bone Indentation Device)
- Device class: 2
- Regulation: 21 CFR 888.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN210013 (2021). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210013: OsteoProbe, Active Life Scientific, Inc. (2021) Summary page 4.

## Most influential descendants
- K250216: OsteoProbe (OP-100) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K221195
Methodology: https://510kreport.com/methodology