510(k) · Cleared
ClearedApollo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norland Corp. · KGI Densitometer, Bone
Cleared on Oct 31, 1997 as substantially equivalent to K891582 (Osteon, Inc., 1989) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 31, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891582 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891582 Modified Osteoanalyzer (# SPSHA110/220)Osteon, Inc. · 1989
- This deviceK972882 ApolloNorland Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891582 | Modified Osteoanalyzer (# SPSHA110/220) | Osteon, Inc. | 1989 | — |
| 0 (this device) | K972882 | Apollo | Norland Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K891582 | Modified Osteoanalyzer (# SPSHA110/220)Summary page 1…pollo™ X-Ray Bone Densitometer Dual energy x-ray bone densitometer Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II OsteoAnalyzer bone densitometer (K891582) Dove Medical Systems, Newbury Park, CA pDEXA bone densitometer (K931996) Norland Corporation, Fort Atkinson, WI Apollo™ is a l… | 1989 |
| * | K931996 | Model Pdexa Bone DensitometerSummary page 1…densitometer, (21 CFR 892.1170), product code 90KGI; Class II OsteoAnalyzer bone densitometer (K891582) Dove Medical Systems, Newbury Park, CA pDEXA bone densitometer (K931996) Norland Corporation, Fort Atkinson, WI Apollo™ is a low cost, portable, easy-to-use bone densitometer which uses low dose x-ray… | 1995 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K891582.
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 Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.
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/K972882 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972882: Apollo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972882
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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