Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Medical Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
214 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120380 | SATURN 8000 | New Medical Co., Ltd. | 2012-03-09 | 31 | 0 |
| K110210 | SATURN 8000-GS | New Medical Co., Ltd. | 2011-04-20 | 85 | 0 |
| K080589 | SATURN 9000-810 | New Medical Co., Ltd. | 2008-06-11 | 100 | 0 |
| K072984 | SATURN 9000-550 | New Medical Co., Ltd. | 2007-11-14 | 22 | 0 |
| K072983 | SATURN 9000-750 | New Medical Co., Ltd. | 2007-11-13 | 21 | 0 |
| K063710 | SATURN 9000 | New Medical Co., Ltd. | 2007-07-16 | 214 | 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