Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Envizion Medical , Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203133 | ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | 2021-03-24 | 156 | 0 |
| K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feed | Envizion Medical , Ltd. | 2019-06-14 | 21 | 0 |
| K182915 | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tub | Envizion Medical , Ltd. | 2019-02-13 | 118 | 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