510(k) · Cleared
ClearedBindex BI-100
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 May 13, 2016 as substantially equivalent to K110646 (Beam-Med, Ltd., 2011) after a 297-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- May 13, 2016
- Review
- 297 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P990035 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP990035 The Sunlight Omnisense (TM) Ultrasound Bone SonometerBeam-Med, Ltd. · 2000
- 1 generation backK110646 Beammed Sunlight Miniomni Bone SonometerBeam-Med, Ltd. · 2011
- This deviceK152020 Bindex BI-100Bone Index Finland, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK161971 Bindex BI-2Bone Index Finland, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK211350 Bindex BI-2Bone Index Finland, Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −2 | P990035 | The Sunlight Omnisense (TM) Ultrasound Bone Sonometer | Beam-Med, Ltd. | 2000 | — |
| −1 | K110646 | Beammed Sunlight Miniomni Bone Sonometer | Beam-Med, Ltd. | 2011 | — |
| 0 (this device) | K152020 | Bindex BI-100 | Bone Index Finland, Ltd. | 2016 | — |
| +1 | K161971 | Bindex BI-2 | Bone Index Finland, Ltd. | 2017 | — |
| +2 | K211350 | Bindex BI-2 | Bone Index Finland, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K110646 | Beammed Sunlight Miniomni Bone SonometerSummary page 4…Bone sonometer Classification Name: Bone sonometer (21 CFR 892.1180) Regulatory Class: II Product Code: MUA III. PREDICATE DEVICE BeamMed MiniOmni bone sonometer, K110646. This predicate has not been subject to a design-related recall.… | 2011 |
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 |
|---|---|---|---|
| K161971 | Bindex BI-2 | 2017 | 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161971 (Bone Index Finland, Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K110646.
How does its category compare?
All MUA devicesMUA Bone Sonometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 as stated in the FDA summary.
https://510kreport.com/device/K152020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152020: Bindex BI-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152020
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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