Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QAI — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
176 daysmedian FDA review time
311 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252591 | Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 | 271 | 0 |
| K253002 | SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | 2026-02-19 | 153 | 0 |
| K252752 | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | 2025-10-30 | 62 | 0 |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025-10-29 | 33 | 0 |
| K243800 | PRO Pen Microneedling System (6883) | Dermalogica, LLC | 2025-08-25 | 257 | 0 |
| K243143 | E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. | 2025-04-07 | 189 | 0 |
| K243472 | 1NEED Pro | Campomats S.R.L. | 2025-03-19 | 131 | 0 |
| K241790 | XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | 2025-03-06 | 258 | 0 |
| K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024-10-09 | 148 | 0 |
| K241400 | SkinPen Precision Elite System | Crown Aesthetics | 2024-08-29 | 104 | 0 |
| K233709 | Exceed Unlimited | Mt. Derm GmbH | 2024-02-23 | 95 | 0 |
| K230420 | Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 | 176 | 0 |
| K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | 2023-07-28 | 105 | 0 |
| K221070 | DP4 Microneedling device | Equipmed USA, LLC | 2022-12-20 | 252 | 0 |
| K221011 | AI.ME System | Venus Concept USA, Inc. | 2022-12-20 | 259 | 0 |
| K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022-10-21 | 91 | 0 |
| K220506 | SkinPen Precision System | Crown Aesthetics | 2022-03-07 | 13 | 0 |
| K212558 | MicroPen EVO | Eclipse Medcorp, LLC | 2021-11-24 | 103 | 0 |
| K202517 | Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | 2021-07-09 | 311 | 2 |
| K203144 | MicroPen EVO | Eclipse Medcorp, LLC | 2021-05-25 | 216 | 0 |
| K202243 | SkinPen Precision System | Crown Aesthetics | 2021-04-02 | 235 | 0 |
| K200044 | SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | 2020-04-10 | 93 | 0 |
| K192138 | Rejuvapen NXT | Refine USA, LLC | 2020-04-09 | 245 | 0 |
| K182407 | Exceed Microneedling device | Mt. Derm GmbH | 2019-07-19 | 318 | 0 |
| K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018-09-07 | 165 | 0 |
| DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018-03-01 | 604 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda