Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ningbo Medsun Medical Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
206 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 | 120 | 0 |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 | 94 | 0 |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 | 57 | 0 |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 | 23 | 0 |
| K232330 | Lancing System | Ningbo Medsun Medical Co., Ltd. | 2024-01-04 | 154 | 0 |
| K221178 | Disposable Insulin Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2022-11-17 | 206 | 0 |
| K222090 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2022-09-30 | 77 | 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