510(k) · Cleared
ClearedReference Population for Norland Apollo X-Ray Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norland Corp. · KGI Densitometer, Bone
Cleared on May 20, 1998 as substantially equivalent to K931996 (Norland Corp., 1995) and 1 other predicate after a 126-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- May 20, 1998
- Review
- 126 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931996 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK931996 Model Pdexa Bone DensitometerNorland Corp. · 1995
- This deviceK980125 Reference Population for Norland Apollo X-Ray Bone DensitometerNorland Corp. · 1998
- Descendant · cites it directly · 0 of its ownK993337 Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K993337Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931996 | Model Pdexa Bone Densitometer | Norland Corp. | 1995 | — |
| 0 (this device) | K980125 | Reference Population for Norland Apollo X-Ray Bone Densitometer | Norland Corp. | 1998 | — |
| +1 | K993337 | Apollo Multi-Racial Reference Population | Norland Medical Systems, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K931996 | Model Pdexa Bone DensitometerSummary page 1…e densitometer Classification: Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class 11 Predicate Devices: Reference Population for pPDEXA™ Bone Densitometer (K931996) Norland Corporation, Fort Atkinson, W1 Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104) Norland Medical Systems… | 1995 |
| * | K973104 | Norland Model Pdexa Bone Densitometer Cleared while this submission was under review Summary page 1…ate Devices: Reference Population for pPDEXA™ Bone Densitometer (K931996) Norland Corporation, Fort Atkinson, W1 Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104) Norland Medical Systems, Inc., Fort Atkinson, W1 Description of The Norland Apollo™ Bone Densitometer (Apollo™) scans the os ca… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993337 | Apollo Multi-Racial Reference Population | 2000 | 0 |
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?
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 bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.
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/K980125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980125: Reference Population for Norland Apollo X-Ray Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980125
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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