Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Jiangxi Hongda Medical Equipment Group , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
161 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211753 | Sterile Syringe With Safety Needle | Jiangxi Hongda Medical Equipment Group , Ltd. | 2021-10-14 | 129 | 0 |
| K210578 | Medical Nitrile Examination Gloves (Power free, Blue) | Jiangxi Hongda Medical Equipment Group , Ltd. | 2021-07-10 | 134 | 0 |
| K210821 | Medical PVC Examination Gloves | Jiangxi Hongda Medical Equipment Group , Ltd. | 2021-07-09 | 112 | 0 |
| K163160 | Sterile Single-use Infusion Set | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-04-20 | 161 | 0 |
| K163161 | Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 | 130 | 0 |
| K163162 | Sterile Hypodermic Safety Syringes for Single Use | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 | 130 | 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