510(k) · Cleared
ClearedDr. pen Microneedling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Ekai Electronic Technology Co., Ltd. · QAI Powered Microneedle Device
Cleared on Aug 11, 2023 as substantially equivalent to DEN160029 (Bellus Medical, LLC, 2018) after a 176-day review. Its family tree reaches back 1 generation to 2018. 3 later devices descend from it.
- Decided
- Aug 11, 2023
- Review
- 176 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160029 (2018). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
- This deviceK230420 Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK252591 Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243800 PRO Pen Microneedling System (6883)Dermalogica, LLC · 2025
- Descendant · cites it directly · 0 of its ownK243472 1NEED ProCampomats S.R.L. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018 | — |
| 0 (this device) | K230420 | Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023 | — |
| +1 | K252591 | Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. | 2026 | — |
| +1 | K243800 | PRO Pen Microneedling System (6883) | Dermalogica, LLC | 2025 | — |
| +1 | K243472 | 1NEED Pro | Campomats S.R.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 QAI? 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 QAI device
- #1 K241355 SER Pen Carain MicroSystem (MP1209SP)score 12.3 · 5 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 |
|---|---|---|---|
| * | DEN160029 | SkinPen Precision SystemSummary page 4…ate Device and Reference Device Information Predicate Device: Trade/Device Name: SkinPen® Precision System K Number: DEN160029 Submitter: Bellus Medical, LLC Reference Device: Trade/Device Name: MicroPen… | 2018 |
| † | K203144 | MicroPen EVO | 2021 |
What descends from it? (3)
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?
How does its category compare?
All QAI devicesQAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QAI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAI
160in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QAI
11in 2025
MAUDE reports naming product code QAI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 4 | 226 | 0 | 2 |
| 2022 | 4 | 172 | 0 | 6 |
| 2023 | 2 | — | 0 | 29 |
| 2024 | 3 | 104 | 0 | 5 |
| 2025 | 6 | 160 | 0 | 11 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Dr.pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230420: Dr. pen Microneedling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230420
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