Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cardio Med Supplies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
175 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080174 | PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH | Cardio Med Supplies, Inc. | 2008-04-23 | 90 | 0 |
| K042672 | 14F DUAL FLOATING DIALYSIS CATHETER/TRAY | Cardio Med Supplies, Inc. | 2005-03-23 | 175 | 0 |
| K021080 | NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS | Cardio Med Supplies, Inc. | 2002-08-29 | 148 | 0 |
| K833112 | TUBING FOR CARDIOPULMONARY BYPASS | Cardio Med Supplies, Inc. | 1983-11-28 | 104 | 0 |
| K802230 | BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP | Cardio Med Supplies, Inc. | 1980-12-22 | 97 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda