510(k) · Cleared
ClearedDPX Bone Densitometer for Total Body Bone Density
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar · KGI Densitometer, Bone
Cleared on Jun 23, 1989 after a 231-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 23, 1989
- Review
- 231 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK884625 DPX Bone Densitometer for Total Body Bone DensityLunar · 1989
- Descendant · cites it directly · 3 of its ownK983564 Prodigy Total Body SoftwareLunar Corp. · 1998
- Descendant · 2 generations on · 1 of its ownK052581 Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK072439 GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007
- Descendant · cites it directly · 0 of its ownK965226 Expert-XL Total Body Acquisition and Analysis SoftwareLunar Corp. · 1997
Most influential descendants
Showing 5 of 5 · See all- K983564Prodigy Total Body SoftwareLunar Corp. · 1998 · cites it directly3descendants
- K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · 2 generations on1descendant
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 3 generations on0descendants
- K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007 · 2 generations on0descendants
- K965226Expert-XL Total Body Acquisition and Analysis SoftwareLunar Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884625 | DPX Bone Densitometer for Total Body Bone Density | Lunar | 1989 | — |
| +1 | K983564 | Prodigy Total Body Software | Lunar Corp. | 1998 | — |
| +2 | K052581 | Lunar Idxa | Ge Medical Systems Ultrasound and Primary Care Dia | 2005 | 1 |
| +3 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +2 | K072439 | GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit | Ge Medical Systems Ultrasound and Primary Care Dia | 2007 | — |
| +1 | K965226 | Expert-XL Total Body Acquisition and Analysis Software | Lunar Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? 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 KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K983564 (Lunar Corp., 1998) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, 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 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K884625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884625: DPX Bone Densitometer for Total Body Bone Density.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884625
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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