510(k) · Cleared
ClearedSER Pen Carain MicroSystem (MP1209SP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Su-Ko Technologies, LLC · QAI Powered Microneedle Device
Cleared on Oct 29, 2025 as substantially equivalent to K241355 (Su-Ko Technologies, LLC, 2024) after a 33-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Oct 29, 2025
- Review
- 33 days
- Class
- Class II
- Product code
- QAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN160029 (2018). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
- 5 generations backK180778 Exceed Microneedling DeviceMt. Derm GmbH · 2018
- 4 generations backK202243 SkinPen Precision SystemCrown Aesthetics · 2021
- 3 generations backK220506 SkinPen Precision SystemCrown Aesthetics · 2022
- 2 generations backK222199 Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022
- 1 generation backK241355 SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2024
- This deviceK253153 SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018 | — |
| −5 | K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018 | — |
| −4 | K202243 | SkinPen Precision System | Crown Aesthetics | 2021 | — |
| −3 | K220506 | SkinPen Precision System | Crown Aesthetics | 2022 | — |
| −2 | K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022 | — |
| −1 | K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024 | — |
| 0 (this device) | K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 K230420 Dr. pen Microneedling Systemscore 14.8 · 1 generation · 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 |
|---|---|---|---|
| * | K241355 | SER Pen Carain MicroSystem (MP1209SP)Summary page 5…de: QAI Submission Type: Special 510(k) (Design Modification) 510(k): K253153 Date: October 28, 2025 3. Predicate Devices Primary Predicate: SER Pen Carain MicroSystem (K241355) The subject device is substantially equivalent to the cleared SER Pen Carain MicroSystem (K241355) with modifications as describ… | 2024 |
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 7 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All QAI devicesQAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253153: SER Pen Carain MicroSystem (MP1209SP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253153
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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