510(k) · Cleared
Recalled · 2004Pediatric Reference Database
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on Aug 11, 2004 as substantially equivalent to K001812 (Lunar Corp., 2000) and 5 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1998. It has been recalled once.
- Decided
- Aug 11, 2004
- Review
- 91 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 4 generations to K973104 (1998). 14 ancestors in all, the oldest K883280 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
- 3 generations backK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
- 2 generations backK023398 Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500…Hologic, Inc. · 2002 · Recalled
- 1 generation backK033224 Hologic QDR Explorer X-Ray Bone Densitometer, Model ExplorerHologic, Inc. · 2003
- This deviceK041266 Pediatric Reference DatabaseHologic, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| −3 | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000… | Hologic, Inc. | 1998 | — |
| −2 | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery | Hologic, Inc. | 2002 | 1 |
| −1 | K033224 | Hologic QDR Explorer X-Ray Bone Densitometer, Model Explorer | Hologic, Inc. | 2003 | — |
| 0 (this device) | K041266 | Pediatric Reference Database | Hologic, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K001812 | Pediatric Reference DataSummary page 1…Densitometer Device Classification Name: Bone Densitometer 21 CFR 8 92.1170 Predicate Devices: Lunar Pediatric Reference Data (1K001812) Expanded. LUNAR Reference Data (1K964307) NHANESjtReference Data for QDR (K963363)… | 2000 |
| * | K964307 | Expanded Reference Values for DPX Bon DensitometersSummary page 1…Densitometer 21 CFR 8 92.1170 Predicate Devices: Lunar Pediatric Reference Data (1K001812) Expanded. LUNAR Reference Data (1K964307) NHANESjtReference Data for QDR (K963363) Hologic® Discovery Package for QDR (1(023398)… | 1997 |
| * | K963363 | Hologic QDR Series X-Ray Boe DensitometersSummary page 1…Devices: Lunar Pediatric Reference Data (1K001812) Expanded. LUNAR Reference Data (1K964307) NHANESjtReference Data for QDR (K963363) Hologic® Discovery Package for QDR (1(023398) Hologic® QDR Explorer X-Ray Bone Densito… | 1996 |
| * | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoverySummary page 1…Expanded. LUNAR Reference Data (1K964307) NHANESjtReference Data for QDR (K963363) Hologic® Discovery Package for QDR (1(023398) Hologic® QDR Explorer X-Ray Bone Densitometer (1(033224) QDR 4500 X-Ray Bone Densitome… | 2002 |
| * | K033224 | Hologic QDR Explorer X-Ray Bone Densitometer, Model ExplorerSummary page 1…Reference Data for QDR (K963363) Hologic® Discovery Package for QDR (1(023398) Hologic® QDR Explorer X-Ray Bone Densitometer (1(033224) QDR 4500 X-Ray Bone Densitometer (1(943505)… | 2003 |
| * | K943505 | Hologic QDR-3000 X-Ray Bone DensitometerSummary page 1…scovery Package for QDR (1(023398) Hologic® QDR Explorer X-Ray Bone Densitometer (1(033224) QDR 4500 X-Ray Bone Densitometer (1(943505) 000008 Holog… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 15, 2004 | Not classified | Z-0192-05 | Other | rotating knob of the rotary style APL valve can become separated from the assembly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 14 ancestors has a recall of any class.
- 4 other devices also cite its predicate K001812.
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 Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The Pediatric Reference Database is for use in determining Z-scores for subjects aged 3-20 years at the discretion of the physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041266: Pediatric Reference Database.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041266
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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