510(k) · Cleared
ClearedModified Osteoanalyzer (# SPSHA110/220)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteon, Inc. · KGI Densitometer, Bone
Cleared on Sep 12, 1989 after a 176-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 12, 1989
- Review
- 176 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK891582 Modified Osteoanalyzer (# SPSHA110/220)Osteon, Inc. · 1989
- Descendant · cites it directly · 3 of its ownK970224 Pixi Bone DensitometerLunar Corp. · 1997
- Descendant · 2 generations on · 0 of its ownK113616 ACCUDXA2Lone Oak Medical Technologies, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK033550 DXL CalscanDemetech AB · 2004
- Descendant · 2 generations on · 0 of its ownK983724 Orca-DX Bone DensitometerLunar Corp. · 1998
- Descendant · cites it directly · 0 of its ownK972882 ApolloNorland Corp. · 1997
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K970224Pixi Bone DensitometerLunar Corp. · 1997 · cites it directly3descendants
- K113616ACCUDXA2Lone Oak Medical Technologies, LLC · 2012 · 2 generations on0descendants
- K033550DXL CalscanDemetech AB · 2004 · 2 generations on0descendants
- K983724Orca-DX Bone DensitometerLunar Corp. · 1998 · 2 generations on0descendants
- K972882ApolloNorland 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) | K891582 | Modified Osteoanalyzer (# SPSHA110/220) | Osteon, Inc. | 1989 | — |
| +1 | K970224 | Pixi Bone Densitometer | Lunar Corp. | 1997 | — |
| +2 | K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | 2012 | — |
| +2 | K033550 | DXL Calscan | Demetech AB | 2004 | — |
| +2 | K983724 | Orca-DX Bone Densitometer | Lunar Corp. | 1998 | — |
| +1 | K972882 | Apollo | Norland Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 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? (6)
3 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, K970224 (Lunar Corp., 1997) 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/K891582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K891582: Modified Osteoanalyzer (# SPSHA110/220).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K891582
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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