Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Venus Concept USA, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
259 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221011 | AI.ME System | Venus Concept USA, Inc. | 2022-12-20 | 259 | 0 |
| K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022-04-27 | 57 | 0 |
| K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022-01-12 | 100 | 0 |
| K211461 | Family of Venus RF Systems - Venus Freedom | Venus Concept USA, Inc. | 2021-10-14 | 156 | 0 |
| K201164 | Venus Viva MD Device | Venus Concept USA, Inc. | 2020-06-26 | 56 | 0 |
| K200786 | Venus Epileve | Venus Concept USA, Inc. | 2020-06-09 | 75 | 0 |
| K191065 | Venus VivaTM | Venus Concept USA, Inc. | 2020-04-01 | 345 | 0 |
| K191528 | Venus Legacy Pro Device | Venus Concept USA, Inc. | 2019-09-06 | 88 | 0 |
| K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019-06-25 | 95 | 0 |
| K182094 | Family of Venus RF Systems - Heal | Venus Concept USA, Inc. | 2019-02-01 | 182 | 0 |
| K142910 | Legacy BX | Venus Concept USA, Inc. | 2014-12-19 | 74 | 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