510(k) · Cleared
ClearedEzRay Air Portable (Model: VEX-P300)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VATECH Co., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Feb 11, 2020 as substantially equivalent to K161063 (VATECH Co., Ltd., 2016) after an 18-day review. Its family tree reaches back 5 generations to 2000. 4 later devices descend from it.
- Decided
- Feb 11, 2020
- Review
- 18 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000061 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 4 generations backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- 3 generations backK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- 2 generations backK081664 Nomad Pro X-Ray SystemAribex, Inc. · 2008 · Recalled
- 1 generation backK161063 EzRay Air (Model VEX-P300)VATECH Co., Ltd. · 2016
- This deviceK200182 EzRay Air Portable (Model: VEX-P300)VATECH Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK222569 Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK252110 Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251438 Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242591 XERO-alphaDRTECH Corporation · 2024
Most influential descendants
Showing 4 of 4 · See all- K222569Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd. · 2022 · cites it directly1descendant
- K252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
- K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument Co., Ltd. · 2025 · 2 generations on0descendants
- K242591XERO-alphaDRTECH Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| −4 | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | 1 |
| −3 | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| −2 | K081664 | Nomad Pro X-Ray System | Aribex, Inc. | 2008 | 2 |
| −1 | K161063 | EzRay Air (Model VEX-P300) | VATECH Co., Ltd. | 2016 | — |
| 0 (this device) | K200182 | EzRay Air Portable (Model: VEX-P300) | VATECH Co., Ltd. | 2020 | — |
| +1 | K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
| +1 | K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025 | — |
| +1 | K242591 | XERO-alpha | DRTECH Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 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? (1)
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 |
|---|---|---|---|
| * | K161063 | EzRay Air (Model VEX-P300)Summary page 4…872.1800) Product Code: EHD Class of Device: Class II Panel: Radiology 510(k) Number: K161063 Page 1 / 5 VATECH Co., Ltd. Premarket Notification 510(k)… | 2016 |
What descends from it? (4)
3 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K222569 (Guilin Woodpecker Medical Instrument Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
EzRay Air Portable (Model: VEX-P300) is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dentist or a dental technician for both adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200182: EzRay Air Portable (Model: VEX-P300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200182
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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