Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical Disposables Intl., Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
57 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771230 | PERCUTANEOUS INTRODUCER SHEATH SET | Medical Disposables Intl., Inc. | 1977-08-16 | 40 | 0 |
| K771231 | ARTEOIAL LINE KIT | Medical Disposables Intl., Inc. | 1977-08-16 | 40 | 0 |
| K770945 | POUCH, TYVEK-POLYMYLON | Medical Disposables Intl., Inc. | 1977-06-29 | 35 | 0 |
| K770699 | NEEDLE SET, A-V FISTULA | Medical Disposables Intl., Inc. | 1977-06-14 | 57 | 0 |
| K770552 | CATHETER, KIDNEY DIALYSIS, HEMO-CATH II | Medical Disposables Intl., Inc. | 1977-03-30 | 9 | 0 |
| K761078 | HEMO-CATH I, KIDNEY DIALYSIS CATHETER | Medical Disposables Intl., Inc. | 1976-12-06 | 17 | 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