PMA · Approved
ApprovedThe Sunlight Omnisense (TM) Ultrasound 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
Approved on Jan 20, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 204-day review. 7 later devices descend from it.
- Decided
- Jan 20, 2000
- Review
- 204 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
7 later devices descend from it, 1 citing it directly.
- This deviceP990035 The Sunlight Omnisense (TM) Ultrasound Bone SonometerBeam-Med, Ltd. · 2000
- Descendant · cites it directly · 6 of its ownK110646 Beammed Sunlight Miniomni Bone SonometerBeam-Med, Ltd. · 2011
- Descendant · 2 generations on · 2 of its ownK180516 EchoSEcholight S.P.A · 2018
- Descendant · 2 generations on · 2 of its ownK152020 Bindex BI-100Bone Index Finland, Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 3 generations on · 1 of its ownK161971 Bindex BI-2Bone Index Finland, Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110646Beammed Sunlight Miniomni Bone SonometerBeam-Med, Ltd. · 2011 · cites it directly6descendants
- K180516EchoSEcholight S.P.A · 2018 · 2 generations on2descendants
- K152020Bindex BI-100Bone Index Finland, Ltd. · 2016 · 2 generations on2descendants
- K202514EchoS FamilyEcholight S.P.A · 2021 · 3 generations on1descendant
- K161971Bindex BI-2Bone Index Finland, Ltd. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P990035 | The Sunlight Omnisense (TM) Ultrasound Bone Sonometer | Beam-Med, Ltd. | 2000 | — |
| +1 | K110646 | Beammed Sunlight Miniomni Bone Sonometer | Beam-Med, Ltd. | 2011 | — |
| +2 | K180516 | EchoS | Echolight S.P.A | 2018 | — |
| +2 | K152020 | Bindex BI-100 | Bone Index Finland, Ltd. | 2016 | — |
| +3 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +3 | K161971 | Bindex BI-2 | Bone Index Finland, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110646 | Beammed Sunlight Miniomni Bone Sonometer | 2011 | 6 |
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?
- Of its descendants, K110646 (Beam-Med, Ltd., 2011) has gone furthest, with 6 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.
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 | — |
https://510kreport.com/device/P990035 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990035: The Sunlight Omnisense (TM) Ultrasound Bone Sonometer.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990035
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026