510(k) · Cleared
ClearedApollo Multi-Racial Reference Population
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norland Medical Systems, Inc. · KGI Densitometer, Bone
Cleared on May 16, 2000 as substantially equivalent to K980125 (Norland Corp., 1998) and 1 other predicate after a 224-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 16, 2000
- Review
- 224 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931996 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931996 | Model Pdexa Bone Densitometer | Norland Corp. | 1995 | — |
| −1 | K980125 | Reference Population for Norland Apollo X-Ray Bone Densitometer | Norland Corp. | 1998 | — |
| 0 (this device) | 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 | 2 | 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 |
|---|---|---|---|
| * | K980125 | Reference Population for Norland Apollo X-Ray Bone DensitometerSummary page 1…DXA bone densitometer Classification: Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II Predicate Devices: Norland Apollo™ with Reference Population (K980125), and Norland Fracture Risk Assessment (K980569) Description of The Apollo™ Multi-Racial Reference Population capability compare… | 1998 |
| * | K980569 | Fracture Risk Assessment Capability for Norland X-Ray Bone DensitometersSummary page 1…sitometer, (21 CFR 892.1170), product code 90KGI; Class II Predicate Devices: Norland Apollo™ with Reference Population (K980125), and Norland Fracture Risk Assessment (K980569) Description of The Apollo™ Multi-Racial Reference Population capability compares Device: patient values to average values for… | 1998 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a 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 bone density estimates from the Apollo™ bone densitometer can he compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than age-related bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women.
The Apollo bone density estimates 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/K993337 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993337: Apollo Multi-Racial Reference Population.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993337
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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