Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medco Products, Co., Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
94 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932466 | MEDCHEM SURGICAL DELIVERY SYSTEM | Medco Products, Co., Inc. | 1993-08-09 | 80 | 0 |
| K913172 | ENDOSCOPIC DELIVERY SYSTEM | Medco Products, Co., Inc. | 1991-09-06 | 51 | 0 |
| K860099 | MEDCO-SONIC NQ-2000 | Medco Products, Co., Inc. | 1986-04-09 | 89 | 0 |
| K852015 | JYROCHAIR, MODEL SK-H | Medco Products, Co., Inc. | 1985-07-19 | 71 | 0 |
| K851659 | SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE | Medco Products, Co., Inc. | 1985-07-01 | 69 | 0 |
| K844580 | MEDCOLATOR MODEL HVX | Medco Products, Co., Inc. | 1985-02-25 | 94 | 0 |
| K842712 | MEDCOLATOR MODEL GX | Medco Products, Co., Inc. | 1984-09-19 | 69 | 0 |
| K822829 | ROTARY VASCULAR KNIFE | Medco Products, Co., Inc. | 1982-11-17 | 57 | 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