Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Feeltech Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025-10-20 | 166 | 0 |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | 2025-10-15 | 273 | 0 |
| K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023-05-31 | 618 | 0 |
| K172602 | Miracu | Feeltech Co., Ltd. | 2018-11-14 | 441 | 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