510(k) · Cleared
ClearedOsteogram Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumed, Inc. · KGI Densitometer, Bone
Cleared on May 19, 1999 after a 169-day review. The FDA summary names its predicate without a number.
- Decided
- May 19, 1999
- Review
- 169 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
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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 |
|---|---|---|---|
| * | — | OsteoGram Named without a submission number |
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.
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 | — |
What is it indicated for?
The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in determining fracture risk, and for for monitoring changes in bone mass over time.
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/K984285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984285: Osteogram Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984285
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026