Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Plast Intl., Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
70 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | Medi-Plast Intl., Inc. | 1996-02-12 | 166 | 0 |
| K873588 | 10CC CONTROL SYRINGE | Medi-Plast Intl., Inc. | 1987-10-23 | 49 | 0 |
| K863402 | MEDI-PLAST DISPOSABLE MANIFOLD | Medi-Plast Intl., Inc. | 1986-10-22 | 49 | 0 |
| K861785 | FLUOROSCOPE BAND BAG | Medi-Plast Intl., Inc. | 1986-06-13 | 36 | 0 |
| K851489 | ARTERIAL-VENOUS COMPRESSION DRESSING | Medi-Plast Intl., Inc. | 1985-06-11 | 57 | 0 |
| K842136 | STERILE PAN SET | Medi-Plast Intl., Inc. | 1984-07-06 | 37 | 0 |
| K840021 | OPERATING ROOM TRAY SET | Medi-Plast Intl., Inc. | 1984-03-15 | 70 | 0 |
| K840022 | HEART CATHETERIZATION TRAY SET | Medi-Plast Intl., Inc. | 1984-02-04 | 30 | 0 |
| K811268 | BOTTLE-TO-BOTTLE | Medi-Plast Intl., Inc. | 1981-06-18 | 44 | 1 |
| K811234 | I.V. BOTTLE (RIDGID) | Medi-Plast Intl., Inc. | 1981-06-18 | 45 | 1 |
| K811233 | I.V. PLASTIC BAG | Medi-Plast Intl., Inc. | 1981-06-17 | 44 | 2 |
| K811269 | GLASS VIALS | Medi-Plast Intl., Inc. | 1981-06-16 | 42 | 1 |
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