Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Daesung Maref Co., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
376 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231437 | LF900 | Daesung Maref Co., Ltd. | 2023-07-19 | 63 | 0 |
| K202395 | SP-1000, SP-2000 | Daesung Maref Co., Ltd. | 2021-09-01 | 376 | 0 |
| K203498 | LX9max | Daesung Maref Co., Ltd. | 2021-07-02 | 217 | 0 |
| K203019 | LF900 | Daesung Maref Co., Ltd. | 2021-06-22 | 264 | 0 |
| K203353 | DVT-PRO | Daesung Maref Co., Ltd. | 2021-04-22 | 160 | 0 |
| K203417 | DVT-4000S | Daesung Maref Co., Ltd. | 2021-03-28 | 129 | 0 |
| K203016 | DVT-2600 | Daesung Maref Co., Ltd. | 2020-12-05 | 65 | 0 |
| K160178 | Lympha-Flow(LF1200) | Daesung Maref Co., Ltd. | 2017-01-11 | 350 | 0 |
| K160180 | Intermittent Pneumatic Compression system | Daesung Maref Co., Ltd. | 2016-11-03 | 281 | 0 |
| K150980 | Venous Assist System | Daesung Maref Co., Ltd. | 2016-05-12 | 394 | 0 |
| K150033 | Air Compressible Limb Therapy System | Daesung Maref Co., Ltd. | 2015-04-20 | 101 | 0 |
| K112441 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM | Daesung Maref Co., Ltd. | 2012-01-17 | 146 | 0 |
| K112677 | THE VENOUS ASSIST SYSTEM | Daesung Maref Co., Ltd. | 2012-01-13 | 121 | 0 |
| K102320 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V | Daesung Maref Co., Ltd. | 2011-03-04 | 199 | 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