Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhenjiang Assure Medical Equipment Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
251 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260319 | K5 wheelchair (16” with swing-away footrest 18” with swing-a | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 | 60 | 0 |
| K251159 | Power wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | 2025-12-22 | 251 | 0 |
| K232230 | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-10-03 | 68 | 0 |
| K232198 | Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 1 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 | 52 | 0 |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’ | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 | 52 | 0 |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-06-05 | 28 | 0 |
| K112816 | ZHENJIANG ASURE MECHANICAL WHEELCHAIR | Zhenjiang Assure Medical Equipment Co., Ltd. | 2012-04-18 | 203 | 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