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 Apr 29, 2022 as substantially equivalent to K161971 (Bone Index Finland, Ltd., 2017) after a 361-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Apr 29, 2022
- Review
- 361 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P990035 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backP990035 The Sunlight Omnisense (TM) Ultrasound Bone SonometerBeam-Med, Ltd. · 2000
- 3 generations backK110646 Beammed Sunlight Miniomni Bone SonometerBeam-Med, Ltd. · 2011
- 2 generations backK152020 Bindex BI-100Bone Index Finland, Ltd. · 2016
- 1 generation backK161971 Bindex BI-2Bone Index Finland, Ltd. · 2017
- This deviceK211350 Bindex BI-2Bone Index Finland, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P990035 | The Sunlight Omnisense (TM) Ultrasound Bone Sonometer | Beam-Med, Ltd. | 2000 | — |
| −3 | K110646 | Beammed Sunlight Miniomni Bone Sonometer | Beam-Med, Ltd. | 2011 | — |
| −2 | K152020 | Bindex BI-100 | Bone Index Finland, Ltd. | 2016 | — |
| −1 | K161971 | Bindex BI-2 | Bone Index Finland, Ltd. | 2017 | — |
| 0 (this device) | K211350 | Bindex BI-2 | Bone Index Finland, Ltd. | 2022 | — |
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
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 |
|---|---|---|---|
| * | K161971 | Bindex BI-2Summary page 5…The associated accessories include: • Measurement stick • Ultrasound gel (optional) II. PREDICATE DEVICES Predicate devices: (1) Bindex BI-2 model (K161971).… | 2017 |
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 22 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All MUA devicesMUA Bone Sonometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/K211350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211350: 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/K211350
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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