Vasamedics, LLC: FDA clearances and approvals
Vasamedics, LLC has 6 FDA 510(k) clearances (first 1991, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time: 188 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | 3 | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 3 | 3 |
Review panels
- Cardiovascular (6)
Most recent Vasamedics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962700 | VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT | DPT | 1997-04-09 | 271 |
| K961368 | TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT | DPT | 1996-10-11 | 185 |
| K951832 | LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433 | DPT | 1996-03-21 | 336 |
| K951486 | MODEL PV2000 VASCULAR MICROLABORATORY | DPW | 1995-06-29 | 91 |
| K912446 | MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 | DPW | 1991-12-12 | 192 |
| K911763 | LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) | DPW | 1991-08-13 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Vasamedics, 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.
Frequently asked questions
How many FDA 510(k) clearances does Vasamedics, LLC have?
Vasamedics, LLC has 6 FDA 510(k) clearances (first 1991, latest 1997), across 2 product codes in 1 review panel.
How long does FDA take to clear Vasamedics, LLC's 510(k)s?
The median time from FDA receipt to decision across Vasamedics, LLC's cleared 510(k)s is 188 days.
What devices does Vasamedics, LLC make?
Its most frequent FDA product codes are DPT (Probe, Blood-Flow, Extravascular, 3); DPW (Flowmeter, Blood, Cardiovascular, 3).
Has Vasamedics, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Vasamedics, LLC. Related entities may recall under other names.
Next steps
- See all 6 Vasamedics, LLC clearances with predicates and recalls
- Run predicate analysis for product code DPT, Vasamedics, 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.