510(k) · Cleared
ClearedBindex BI-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bone Index Finland, Ltd. · MUA Bone Sonometer
Cleared on Jan 9, 2017 as substantially equivalent to K152020 (Bone Index Finland, Ltd., 2016) after a 175-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jan 9, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P990035 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP990035 The Sunlight Omnisense (TM) Ultrasound Bone SonometerBeam-Med, Ltd. · 2000
- 2 generations backK110646 Beammed Sunlight Miniomni Bone SonometerBeam-Med, Ltd. · 2011
- 1 generation backK152020 Bindex BI-100Bone Index Finland, Ltd. · 2016
- This deviceK161971 Bindex BI-2Bone Index Finland, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK211350 Bindex BI-2Bone Index Finland, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K211350Bindex BI-2Bone Index Finland, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P990035 | The Sunlight Omnisense (TM) Ultrasound Bone Sonometer | Beam-Med, Ltd. | 2000 | — |
| −2 | K110646 | Beammed Sunlight Miniomni Bone Sonometer | Beam-Med, Ltd. | 2011 | — |
| −1 | K152020 | Bindex BI-100 | Bone Index Finland, Ltd. | 2016 | — |
| 0 (this device) | K161971 | Bindex BI-2 | Bone Index Finland, Ltd. | 2017 | — |
| +1 | K211350 | Bindex BI-2 | Bone Index Finland, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 MUA? 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 MUA device
- #1 K202514 EchoS Familyscore 5.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K152020 | Bindex BI-100Summary page 4…me: Bone sonometer Classification Name: Bone sonometer (21 CFR 892.1180) Regulatory Class: II Product Code: MUA III. PREDICATE DEVICE Bindex BI-100 bone sonometer, K152020. This predicate has not been subject to a design-related recall.… | 2016 |
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 |
|---|---|---|---|
| K211350 | Bindex BI-2 | 2022 | 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211350 (Bone Index Finland, Ltd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUA devicesMUA Bone Sonometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUA
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MUA
Too few MUA 510(k)s in any year since 2007 to give a median.
Recalls per year · MUA
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUA
1in 2011
MAUDE reports naming product code MUA, not matched to any one device; reports are not rates.
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 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161971: Bindex BI-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161971
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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