510(k) · Cleared

Cleared

Pediatric Reference Data

K001812510(k) TraditionalCleared Jul 10, 200025-day reviewClass II21 CFR 892.1170

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lunar Corp. · KGI Densitometer, Bone

Cleared on Jul 10, 2000 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided: Jul 10, 2000
Review: 25 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 0

22 later devices descend from it, 5 citing it directly.

This deviceK001812 Pediatric Reference DataLunar Corp. · 2000
Descendant · cites it directly · 19 of its ownK023398 Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500…Hologic, Inc. · 2002 · Recalled
Descendant · 2 generations on · 13 of its ownK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
Descendant · 3 generations on · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
Descendant · 3 generations on · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
Descendant · 4 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2002high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 22 · See all

K023398Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoveryHologic, Inc. · 2002 · cites it directly19descendants
K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc. · 2006 · 2 generations on13descendants
K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · 3 generations on7descendants
K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 3 generations on6descendants
K121716TBS InsightMedimaps Group SA · 2012 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001812	Pediatric Reference Data	Lunar Corp.	2000	—
+1	K023398	Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery	Hologic, Inc.	2002	1
+2	K061561	Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone…	Hologic, Inc.	2006	—
+3	K072664	GE Lunar Femur Strength Software	Ge Medical Systems Ultrasound and Primary Care Dia	2008	—
+3	K082402	Osdx Hip BMD System	Imaging Therapeutics, Inc.	2008	—
+4	K121716	TBS Insight	Medimaps Group SA	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2006	1	0
2007	1	0
2008	3	0
2012	2	0
2014	1	0
2016	2	0
2018	1	0
2019	1	0
2022	1	0
2023	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K001812, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023398	Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery	Hologic, Inc.	2002	19
K052581	Lunar Idxa	Ge Medical Systems Ultrasound and Primary Care Dia	2005	1
K133664	Encore Version 16 Software for GE Lunar Dxa Bone Densitometers	Ge Medical Systems Ultrasound & Primary Care Diagn	2014	0
K072439	GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit	Ge Medical Systems Ultrasound and Primary Care Dia	2007	0
K041266	Pediatric Reference Database	Hologic, Inc.	2004	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?

Of its descendants, K023398 (Hologic, Inc., 2002) has gone furthest, with 19 descendants of its own.

How does its category compare?

All KGI devices

KGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGI

3in 2025

2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGI

156in 2025

2007high 173 (2008) · low 142 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGI

1in 2016

2007high 9 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGI

8in 2025

2007high 16 (2017) · low 0 (2007)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	—

https://510kreport.com/device/K001812 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001812: Pediatric Reference Data.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001812

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026