Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wonjin Mulsan Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
371 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211283 | Compressible Limb and Circulation Therapy System, Model POWE | Wonjin Mulsan Co., Ltd. | 2021-09-14 | 140 | 0 |
| K200660 | Compressible Limb and Circulation Therapy System | Wonjin Mulsan Co., Ltd. | 2021-03-08 | 361 | 0 |
| K113275 | COMPRESSIBLE LIMB THERAPY SYSTEM | Wonjin Mulsan Co., Ltd. | 2012-02-27 | 115 | 0 |
| K100656 | COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 | Wonjin Mulsan Co., Ltd. | 2010-05-26 | 79 | 0 |
| K080134 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF- | Wonjin Mulsan Co., Ltd. | 2009-01-23 | 371 | 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