Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kunshan Jiehong Nonwoven Product Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STER | Kunshan Jiehong Nonwoven Product Co., Ltd. | 2011-09-29 | 65 | 0 |
| K111067 | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL | Kunshan Jiehong Nonwoven Product Co., Ltd. | 2011-08-02 | 106 | 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