510(k) · Cleared
ClearedPreXion3D Explorer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prexion Corporation · OAS X-Ray, Tomography, Computed, Dental
Cleared on Apr 15, 2019 after a 61-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Apr 15, 2019
- Review
- 61 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK190320 PreXion3D ExplorerPrexion Corporation · 2019
- Descendant · cites it directly · 8 of its ownK193329 PreXion3D Explorer EXPrexion Corporation · 2020
- Descendant · cites it directly · 6 of its ownK203784 PreXion3D Explorer PROPrexion Corporation · 2021
- Descendant · 2 generations on · 3 of its ownK221525 PreXion3D Explorer PROPrexion Corporation · 2022
- Descendant · 3 generations on · 2 of its ownK232710 Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK222150 PreXion3D ExpeditionPrexion Corporation · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K193329PreXion3D Explorer EXPrexion Corporation · 2020 · cites it directly8descendants
- K203784PreXion3D Explorer PROPrexion Corporation · 2021 · cites it directly6descendants
- K221525PreXion3D Explorer PROPrexion Corporation · 2022 · 2 generations on3descendants
- K232710Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. · 2024 · 3 generations on2descendants
- K222150PreXion3D ExpeditionPrexion Corporation · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190320 | PreXion3D Explorer | Prexion Corporation | 2019 | — |
| +1 | K193329 | PreXion3D Explorer EX | Prexion Corporation | 2020 | — |
| +1 | K203784 | PreXion3D Explorer PRO | Prexion Corporation | 2021 | — |
| +2 | K221525 | PreXion3D Explorer PRO | Prexion Corporation | 2022 | — |
| +3 | K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024 | — |
| +2 | K222150 | PreXion3D Expedition | Prexion Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K193329 (Prexion Corporation, 2020) has gone furthest, with 8 descendants of its own.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
https://510kreport.com/device/K190320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190320: PreXion3D Explorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190320
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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