Avco Medical Products: FDA clearances and approvals
Avco Medical Products has 5 FDA 510(k) clearances (first 1977, latest 1981), across 2 product codes in 1 review panel. Median 510(k) review time: 92 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 4 | 4 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Avco Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802924 | KONTRON PERCUTAEOUS DOUBLE-LUMEN | DSP | 1981-03-11 | 113 |
| K790241 | INTRA-AORTIC BALLOON-PUMP | DSP | 1979-02-23 | 22 |
| K781848 | PUMP, BALLOON MODEL 10 | DSP | 1979-01-23 | 92 |
| K770937 | PUMP, BYPASS, PULSATILE, AVCO | KFM | 1977-11-17 | 178 |
| K770821 | PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT | DSP | 1977-05-06 | 2 |
Recalls
openFDA lists no recalls under a recalling firm named Avco Medical Products.
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 Avco Medical Products have?
Avco Medical Products has 5 FDA 510(k) clearances (first 1977, latest 1981), across 2 product codes in 1 review panel.
How long does FDA take to clear Avco Medical Products's 510(k)s?
The median time from FDA receipt to decision across Avco Medical Products's cleared 510(k)s is 92 days.
What devices does Avco Medical Products make?
Its most frequent FDA product codes are DSP (System, Balloon, Intra-Aortic And Control, 4); KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 1).
Has Avco Medical Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Avco Medical Products. Related entities may recall under other names.
Next steps
- See all 5 Avco Medical Products clearances with predicates and recalls
- Run predicate analysis for product code DSP, Avco Medical Products'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.