Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medline Industires, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
448 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (17 | Medline Industires, Inc. | 2023-06-23 | 448 | 0 |
| K201129 | Medline Smoke Evacuation Pencil | Medline Industires, Inc. | 2020-10-16 | 171 | 0 |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested f | Medline Industires, Inc. | 2020-09-18 | 114 | 0 |
| K200960 | Medline Powder Free Examination Gloves (Tested for use with | Medline Industires, Inc. | 2020-07-13 | 94 | 0 |
| K201319 | Medline UNITE Jones Fracture Screw System | Medline Industires, Inc. | 2020-06-17 | 30 | 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