510(k) · Cleared
ClearedPixi Young Adult Referenc Population for OS Calcis and Forearm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar Corp. · KGI Densitometer, Bone
Cleared on Aug 8, 1997 as substantially equivalent to K891582 (Osteon, Inc., 1989) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 8, 1997
- Review
- 67 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891582 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891582 Modified Osteoanalyzer (# SPSHA110/220)Osteon, Inc. · 1989
- This deviceK972053 Pixi Young Adult Referenc Population for OS Calcis and ForearmLunar Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891582 | Modified Osteoanalyzer (# SPSHA110/220) | Osteon, Inc. | 1989 | — |
| 0 (this device) | K972053 | Pixi Young Adult Referenc Population for OS Calcis and Forearm | Lunar Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K891582 | Modified Osteoanalyzer (# SPSHA110/220)Summary page 1…-0853 May 29, 1997 PIXI™ young adult reference population for os calcis and forearm. Bone Densitometer Bone Densitometer 21CFR 892.1170 Osteon Osteoanalyzer 510 (k) K891582 Norland pDEXA 510 (k) K931996 10.1 DESCRIPTION OF DEVICE The reference BMD values incorporated in this submission, provides th… | 1989 |
| * | K931996 | Model Pdexa Bone DensitometerSummary page 1…g adult reference population for os calcis and forearm. Bone Densitometer Bone Densitometer 21CFR 892.1170 Osteon Osteoanalyzer 510 (k) K891582 Norland pDEXA 510 (k) K931996 10.1 DESCRIPTION OF DEVICE The reference BMD values incorporated in this submission, provides the ability to compare the BMD re… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K891582.
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 PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value. This additional feature is highly comparable to similar features in the Norland…
Read the full statement (139 words)
The PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value.
This additional feature is highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers.
The use of the PIXI™ young adult reference population for os calcis and forearm, is restricted to prescription use only. The operator’s manual for the PIXI system contains the following statement:
“United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician.”
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/K972053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972053: Pixi Young Adult Referenc Population for OS Calcis and Forearm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972053
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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