510(k) · Cleared
Recalled · 20081.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on Sep 2, 2008 as substantially equivalent to K963363 (Hologic, Inc., 1996) and 1 other predicate after a 173-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 2, 2008
- Review
- 173 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973104 (1998). 3 ancestors in all, the oldest K963363 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
- 1 generation backK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
- This deviceK080711 1.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone…Hologic, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK091325 Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa…Cooper Surgical · 2009
Most influential descendants
Showing 1 of 1 · See all- K091325Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone DensitometersCooper Surgical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| −1 | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000… | Hologic, Inc. | 1998 | — |
| 0 (this device) | K080711 | 1.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer… | Hologic, Inc. | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K963363 | Hologic QDR Series X-Ray Boe DensitometersSummary page 2…Bone Densitometer: 21 CFR 892.1170 G.3.3 Classification Panel Radiology G.3.4 Product Code 90 KGI G.3.5 Predicate Devices * 510(k) No.: K963363 Trade Name: NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers… | 1996 |
| * | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…Summary page 2…for Hologic QDR Series X-Ray Bone Densitometers SE Date: November 22, 1996 Manufacturer: Hologic, Inc. · 510(k)No.: K983028 Trade Name: Estimation of Fracture Risk from BMD using Hologic QDR X-Ray Bone Densitometers… | 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 |
|---|---|---|---|
| K091325 | Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone Densitometers | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2008 | Not classified | Z-0449-2009 | Software design | Software error may lead to a high estimate of major fracture probability. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091325 (Cooper Surgical, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K963363.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Femoral neck BMD and clinical risk factors are used to estimate 10-year risk of hip fracture and 10-year risk of major osteoporotic fracture using the World Health Organization (WHO) algorithm (FRAXTM) in adults. The physician may use the 10-year fracture risk, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080711: 1.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080711
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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