Cardio Med Supplies, Inc.: FDA clearances and approvals
Cardio Med Supplies, Inc. has 5 FDA 510(k) clearances (first 1980, latest 2008), across 5 product codes in 3 review panels. Median 510(k) review time: 104 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| FIF | Set, Dialysis, Single Needle With Uni-Directional Pump | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 | 1 |
Review panels
Most recent Cardio Med Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080174 | PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C | LHI | 2008-04-23 | 90 |
| K042672 | 14F DUAL FLOATING DIALYSIS CATHETER/TRAY | MSD | 2005-03-23 | 175 |
| K021080 | NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS | FPA | 2002-08-29 | 148 |
| K833112 | TUBING FOR CARDIOPULMONARY BYPASS | DWF | 1983-11-28 | 104 |
| K802230 | BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP | FIF | 1980-12-22 | 97 |
Recalls
openFDA lists no recalls under a recalling firm named Cardio Med Supplies, Inc..
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 Cardio Med Supplies, Inc. have?
Cardio Med Supplies, Inc. has 5 FDA 510(k) clearances (first 1980, latest 2008), across 5 product codes in 3 review panels.
How long does FDA take to clear Cardio Med Supplies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cardio Med Supplies, Inc.'s cleared 510(k)s is 104 days.
What devices does Cardio Med Supplies, Inc. make?
Its most frequent FDA product codes are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1); FIF (Set, Dialysis, Single Needle With Uni-Directional Pump, 1); FPA (Set, Administration, Intravascular, 1).
Has Cardio Med Supplies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cardio Med Supplies, Inc. Related entities may recall under other names.
Next steps
- See all 5 Cardio Med Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Cardio Med Supplies, Inc.'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.