Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sumitomo Bakelite Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182520 | Flexible Overtube | Sumitomo Bakelite Co., Ltd. | 2019-05-15 | 244 | 0 |
| K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr typ | Sumitomo Bakelite Co., Ltd. | 2019-04-23 | 43 | 0 |
| K173004 | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | Sumitomo Bakelite Co., Ltd. | 2018-05-08 | 223 | 0 |
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard typ | Sumitomo Bakelite Co., Ltd. | 2016-06-17 | 266 | 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