Vantive US Healthcare, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Vantive US Healthcare, LLC” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 161 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 161 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vantive US Healthcare, LLC took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 206 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 | 1 |
| MDP | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | 1 | 0 |
Review panels
Most recent Vantive US Healthcare, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250508 | AK 98 Dialysis Machine (955607) | KDI | 2025-08-01 | 161 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P830063 | PMA | GAMBRO FIBER PLASMAFILTER | 1986-05-27 |
Recalls
12 product recalls in 3 recall events; 12 initiated in the last five years. Most recent: 2026-01-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vantive US Healthcare, LLC?
FDA lists 1 510(k) clearance under the applicant name “Vantive US Healthcare, LLC” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vantive US Healthcare, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vantive US Healthcare, LLC is 161 days.
Which FDA product codes appear under Vantive US Healthcare, LLC?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 1); MDP (Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma, 1).
Next steps
- See all 1 Vantive US Healthcare, LLC clearances with predicates and recalls
- Run predicate analysis for product code KDI, Vantive US Healthcare, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.