510(k) · Cleared
ClearedBeammed Sunlight Miniomni Bone Sonometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beam-Med, Ltd. · MUA Bone Sonometer
Cleared on Oct 12, 2011 as substantially equivalent to P990035 (Beam-Med, Ltd., 2000) after a 222-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Oct 12, 2011
- Review
- 222 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P990035 (2000). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP990035 The Sunlight Omnisense (TM) Ultrasound Bone SonometerBeam-Med, Ltd. · 2000
- This deviceK110646 Beammed Sunlight Miniomni Bone SonometerBeam-Med, Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK180516 EchoSEcholight S.P.A · 2018
- Descendant · cites it directly · 2 of its ownK152020 Bindex BI-100Bone Index Finland, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 2 generations on · 1 of its ownK161971 Bindex BI-2Bone Index Finland, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK211350 Bindex BI-2Bone Index Finland, Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180516EchoSEcholight S.P.A · 2018 · cites it directly2descendants
- K152020Bindex BI-100Bone Index Finland, Ltd. · 2016 · cites it directly2descendants
- K202514EchoS FamilyEcholight S.P.A · 2021 · 2 generations on1descendant
- K161971Bindex BI-2Bone Index Finland, Ltd. · 2017 · 2 generations on1descendant
- K211350Bindex BI-2Bone Index Finland, Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P990035 | The Sunlight Omnisense (TM) Ultrasound Bone Sonometer | Beam-Med, Ltd. | 2000 | — |
| 0 (this device) | K110646 | Beammed Sunlight Miniomni Bone Sonometer | Beam-Med, Ltd. | 2011 | — |
| +1 | K180516 | EchoS | Echolight S.P.A | 2018 | — |
| +1 | K152020 | Bindex BI-100 | Bone Index Finland, Ltd. | 2016 | — |
| +2 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +2 | K161971 | Bindex BI-2 | Bone Index Finland, Ltd. | 2017 | — |
| +3 | K211350 | Bindex BI-2 | Bone Index Finland, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | P990035 | The Sunlight Omnisense (TM) Ultrasound Bone SonometerSummary page 2…order to operate as intended. The MiniOmni has been developed from the Sunlight Omnisense 7000S device, which was originally approved for sale in the US by means of PMA P990035. In August 2008, FDA down- classified Bone Sonometers in Product Code MUA to Class 11,special controls. This 51 0(k) submission i… | 2000 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K180516 (Echolight S.P.A, 2018) has gone furthest, with 2 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. 2011, 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?
The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of Ultrasound waves ("Speed of Sound' or "SOS" in rn/seo) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility. The output is also expressed as a T-score and a Z-score, and can be…
Read the full statement (198 words)
The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of Ultrasound waves ("Speed of Sound' or "SOS" in rn/seo) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility.
The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.
Multiple skeletal site testing provided clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture.
The SOS measured by MiniOmni has a precision error low enough in comparison with the, expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110646: Beammed Sunlight Miniomni Bone Sonometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110646
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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