510(k) · Cleared
ClearedACCUDXA2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lone Oak Medical Technologies, LLC · KGI Densitometer, Bone
Cleared on Apr 27, 2012 as substantially equivalent to K971735 (Schick Technologies, Inc., 1997) and 4 other predicates after a 142-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Apr 27, 2012
- Review
- 142 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K891582 (1989). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891582 | Modified Osteoanalyzer (# SPSHA110/220) | Osteon, Inc. | 1989 | — |
| −1 | K970224 | Pixi Bone Densitometer | Lunar Corp. | 1997 | — |
| 0 (this device) | K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K971735 | Accudexa Bone DensitometerSummary page 3…ust 2007. This design was repackaged and updated to reduce the size and weight of the unit. The same algorithms, normative database and sensor used in the Schick design (K971735, K981 124, K001429) are used in the Lone Oak design. The software changes to the Schick design concern the Graphical User Interfa… | 1997 |
| * | K981124 | Accudexa Bone DensitometerSummary page 1…name Product Code 51 0(k) Schick accuDEXA Bone KGI K(971735, Technologies Densitometer K981 124, KO001429 Alara, Inc Metriscan Bone KGI… | 1998 |
| * | K001429 | Modification to Accudexa Bone DensitometerSummary page 3…gn was repackaged and updated to reduce the size and weight of the unit. The same algorithms, normative database and sensor used in the Schick design (K971735, K981 124, K001429) are used in the Lone Oak design. The software changes to the Schick design concern the Graphical User Interface, Operating Syste… | 2000 |
| * | K000162 | Metriscan Bone Density SystemSummary page 1…meter K981 124, KO001429 Alara, Inc Metriscan Bone KGI K000162 Density System Lunar Corp PIXI KGI K970224… | 2000 |
| * | K970224 | Pixi Bone DensitometerSummary page 1…429 Alara, Inc Metriscan Bone KGI K000162 Density System Lunar Corp PIXI KGI K970224 Page 5 Device Description: The Accudxa 2 Model 7200 is a Dual Energy X-r… | 1997 |
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 23 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Accudxa 2 is a dual-energy x-ray (DXA) device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMVD). This BMD value is a relative indicator of bone density elsewhere in the body. Accudxa 2 BMD estimates, t-score and z-score can be used as an aid to the physician in determining fracture risk and for monitoring changes in bone mass over time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113616: ACCUDXA2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113616
Report an extraction error
Are you the manufacturer?
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