510(k) · Cleared
ClearedTen-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone Densitometers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cooper Surgical · KGI Densitometer, Bone
Cleared on Jun 29, 2009 as substantially equivalent to K080711 (Hologic, Inc., 2008) and 1 other predicate after a 55-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 29, 2009
- Review
- 55 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935454 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
- 2 generations backK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
- 1 generation backK071570 GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007
- This deviceK091325 Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa…Cooper Surgical · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935454 | DPX Tissue Quantification Output | Lunar Corp. | 1995 | — |
| −2 | K973459 | Norland Body Composition Option for Norland Dexa Bone Densitometers | Norland Corp. | 1998 | — |
| −1 | K071570 | GE Lunar Body Composition Software | Ge Medical Systems Lunar | 2007 | — |
| 0 (this device) | K091325 | Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone… | Cooper Surgical | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K080711 | 1.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR…Summary page 1…ptions 7. Classification DXA Bone Densitometer, 90 KGI, Class 11, Section 892.1170 8. Predicate Device Comparison Ten-Year Fracture Risk Option K0807 11, Hologic 10-year Fracture Risk Questionnaire Option. The Norland Ten-Year Fracture Risk Option is substantially equival… | 2008 |
| * | K071570 | GE Lunar Body Composition SoftwareSummary page 1…to estimate the patient's risk of hip fracture and major osteoporotic fracture. No new safety or efficacy questions are raised. SIRI Table Option K071570, GE Lunar Body Composition Software Option. K014009 - Tanita Body Composition Analyzer The Norland SIRI Table Opti… | 2007 |
| † | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | 2002 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Ten-Year Fracture Risk Option The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's ten-year risk of a hip fracture and/or a major osteoporodic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to…
Read the full statement (238 words)
Ten-Year Fracture Risk Option
The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's ten-year risk of a hip fracture and/or a major osteoporodic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.
SIRI Table Option
The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This option also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091325 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091325: Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone Densitometers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091325
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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