Medline Industries, Inc.: FDA filings under this applicant name
FDA lists 268 510(k) clearances under the applicant name “Medline Industries, Inc.” (first 1977, latest 2026), plus 1 De Novo decision, across 110 product codes in 11 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 156 days, against 136 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 144 |
| 2013 | 5 | 218 |
| 2014 | 4 | 188 |
| 2015 | 10 | 214 |
| 2016 | 11 | 267 |
| 2017 | 7 | 239 |
| 2018 | 11 | 115 |
| 2019 | 11 | 140 |
| 2020 | 16 | 134 |
| 2021 | 9 | 136 |
| 2022 | 12 | 166 |
| 2023 | 9 | 156 |
| 2024 | 10 | 182 |
| 2025 | 5 | 149 |
| 2026 | 4 | 217 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medline Industries, Inc. took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 16 | 16 |
| LZA | Polymer Patient Examination Glove | 13 | 13 |
| KGO | Surgeon'S Gloves | 12 | 12 |
| FRG | Wrap, Sterilization | 11 | 11 |
| FRO | Dressing, Wound, Drug | 9 | 9 |
| INI | Vehicle, Motorized 3-Wheeled | 9 | 9 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| LYY | Latex Patient Examination Glove | 8 | 8 |
| HRS | Plate, Fixation, Bone | 6 | 6 |
| KKX | Drape, Surgical, Antimicrobial | 6 | 6 |
Plus 100 more product codes.
Review panels
- General Hospital (110)
- General and Plastic Surgery (45)
- Gastroenterology and Urology (34)
- Anesthesiology (17)
- Orthopedic (17)
- Cardiovascular (16)
- Physical Medicine (14)
- Obstetrics and Gynecology (11)
- Clinical Chemistry (2)
- Neurology (1)
- Clinical Toxicology (1)
Most recent Medline Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | DYB | 2026-07-29 | 258 |
| K254287 | Medline Reusable Blood Pressure Cuff | DXQ | 2026-06-22 | 173 |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | BZE | 2026-03-25 | 176 |
| K251687 | Konig Bell Circumcision Clamp | HFX | 2026-02-25 | 268 |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | DXC | 2025-11-20 | 58 |
| K250345 | Medline Bag Decanter | LHI | 2025-10-24 | 260 |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | BTT | 2025-07-02 | 149 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | JDR | 2025-04-11 | 114 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | FYA | 2025-02-26 | 159 |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | GEI | 2024-12-19 | 132 |
258 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210049 | De Novo | Semi-Automated Autologous Skin Graft Harvesting And Application Device | 2024-03-27 |
Recalls
687 product recalls in 134 recall events; 557 initiated in the last five years. Most recent: 2026-08-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Medline Industries, Inc. is the lead sponsor of 12 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05756348: Durability of Two Skin Barrier Protectants (SBP) (Completed, started 2022-10-06)
- NCT05250102: Neonatal Pulse Oximetry Sensor Study (Completed, started 2022-06-13)
- NCT05454813: Wetness Sensing System (Completed, started 2022-06-08)
- NCT05376787: Verify the Performance of the Neutral Electrode (NE) Adhesives (Completed, started 2022-05-30)
- NCT03645967: Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates (Completed, started 2018-08-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medline Industries, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medline (11 510(k)s)
- Medline Industires, Inc. (6 510(k)s)
- Medline Products Co. , Ltd. (1 510(k)s)
- Medline Renewal (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medline Industries, Inc.?
FDA lists 268 510(k) clearances under the applicant name “Medline Industries, Inc.” (first 1977, latest 2026), plus 1 De Novo decision, across 110 product codes in 11 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medline Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medline Industries, Inc. is 116 days. Since 2017: 156 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medline Industries, Inc.?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 16); LZA (Polymer Patient Examination Glove, 13); KGO (Surgeon'S Gloves, 12).
Next steps
- See all 268 Medline Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FYA, Medline Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.