# QAI: Powered Microneedle Device

- Device class: 2; regulation: 21 CFR 878.4430; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 148 days (middle half 99–244)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 2
- 2019: 1
- 2020: 2
- 2021: 4
- 2022: 4
- 2023: 2
- 2024: 3
- 2025: 6
- 2026: 2

## Most-cited predicates
- DEN160029: SkinPen Precision System (2018), cited by 9
- K180778: Exceed Microneedling Device (2018), cited by 4
- K230420: Dr. pen Microneedling System (2023), cited by 3
- K222199: Collagen P.I.N. (Percutaneous Induction Needling) (2022), cited by 2
- K202517: Cytrellis Dermal Micro-Coring System (2021), cited by 2
- K220506: SkinPen Precision System (2022), cited by 2
- K202243: SkinPen Precision System (2021), cited by 2
- K182407: Exceed Microneedling device (2019), cited by 2
- K241355: SER Pen Carain MicroSystem (MP1209SP) (2024), cited by 1
- K200044: SkinStylus SteriLock MicroSystem (2020), cited by 1

Source page: https://510kreport.com/product-code/QAI
Data by year (CSV): https://510kreport.com/product-code/QAI.csv