Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sunder Biomedical Tech. Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K024007 | SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND S | Sunder Biomedical Tech. Co., Ltd. | 2003-07-14 | 222 | 0 |
| K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLO | Sunder Biomedical Tech. Co., Ltd. | 2002-11-18 | 336 | 0 |
| K003123 | RENAX A.V. FISTULA NEEDLE SETS | Sunder Biomedical Tech. Co., Ltd. | 2001-05-04 | 211 | 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