Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beijing Zksk Technology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
250 daysmedian FDA review time
411 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | 2025-02-06 | 195 | 0 |
| K231721 | Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. | 2023-12-14 | 184 | 0 |
| K213217 | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | 2022-11-14 | 411 | 0 |
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | 2022-06-06 | 250 | 0 |
| K213222 | Disposable Polypectomy Snare | Beijing Zksk Technology Co., Ltd. | 2022-06-06 | 250 | 0 |
| K213239 | Endoscopic Injection Needle | Beijing Zksk Technology Co., Ltd. | 2022-06-02 | 245 | 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