Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lee Medical Intl., Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
81 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840083 | STERILE INSULIN DISPOS. NEEDLE/GREEN | Lee Medical Intl., Inc. | 1984-02-21 | 42 | 0 |
| K840081 | IV ADMINISTRATION SET | Lee Medical Intl., Inc. | 1984-02-21 | 42 | 0 |
| K840082 | STERILE INSULIN DISPOS. NEEDLE/SYRINGE | Lee Medical Intl., Inc. | 1984-02-21 | 42 | 0 |
| K832101 | STERILE DISPOSABLE SYRINGE | Lee Medical Intl., Inc. | 1983-09-12 | 81 | 0 |
| K832105 | ADMINISTRATIVE IV SET | Lee Medical Intl., Inc. | 1983-09-12 | 81 | 0 |
| K832104 | STERILE DISP. BUTTERFLY INFUSION SET | Lee Medical Intl., Inc. | 1983-09-12 | 81 | 0 |
| K832102 | STERILE DISPOSABLE NEEDLES | Lee Medical Intl., Inc. | 1983-09-01 | 70 | 0 |
| K832103 | BLOOD TUBING SET | Lee Medical Intl., Inc. | 1983-08-12 | 50 | 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