Lifevac, LLC: FDA clearances and approvals
Lifevac, LLC has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QXN | Suction Anti-Choking Device As A Second-Line Treatment | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250012 | De Novo | Suction Anti-Choking Device As A Second-Line Treatment | 2026-03-04 |
Recalls
openFDA lists no recalls under a recalling firm named Lifevac, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Lifevac, LLC is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06659796: LifeVac Survey Study (Completed, started 2024-06-24)
Frequently asked questions
How many FDA 510(k) clearances does Lifevac, LLC have?
Lifevac, LLC has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Lifevac, LLC make?
Its most frequent FDA product codes are QXN (Suction Anti-Choking Device As A Second-Line Treatment, 1).
Has Lifevac, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Lifevac, LLC. Related entities may recall under other names.
Next steps
- See all 0 Lifevac, LLC clearances with predicates and recalls
- Run predicate analysis for product code QXN, Lifevac, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.