Medline Industires, Inc.: FDA clearances and approvals
Medline Industires, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2024), across 6 product codes in 4 review panels. Median 510(k) review time: 104 days. Since 2017 its median was 104 days, against 109 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 4 | 104 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 448 |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medline Industires, Inc.'s cleared 510(k)s took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
Most recent Medline Industires, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234031 | Medline UNITE Ancillary Foot Recon Plating System | HRS | 2024-01-18 | 29 |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | CAF | 2023-06-23 | 448 |
| K201129 | Medline Smoke Evacuation Pencil | GEI | 2020-10-16 | 171 |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | LZC | 2020-09-18 | 114 |
| K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | LZA | 2020-07-13 | 94 |
| K201319 | Medline UNITE Jones Fracture Screw System | HWC | 2020-06-17 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Medline Industires, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medline Industires, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Medline Industires, Inc. have?
Medline Industires, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2024), across 6 product codes in 4 review panels.
How long does FDA take to clear Medline Industires, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medline Industires, Inc.'s cleared 510(k)s is 104 days. Since 2017: 104 days, versus 109 days for all cleared 510(k)s in the same product codes.
What devices does Medline Industires, Inc. make?
Its most frequent FDA product codes are CAF (Nebulizer (Direct Patient Interface), 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); HRS (Plate, Fixation, Bone, 1).
Has Medline Industires, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medline Industires, Inc. Related entities may recall under other names.
Next steps
- See all 6 Medline Industires, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Medline Industires, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.