Medline Industries, LP: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Medline Industries, LP” (first 2022, latest 2026), across 20 product codes in 6 review panels. Median 510(k) review time under this name: 159 days. Since 2017 the median was 159 days, against 127 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 |
|---|---|---|
| 2022 | 6 | 120 |
| 2023 | 6 | 134 |
| 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, LP took a median 159 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 3 | 3 |
| FYA | Gown, Surgical | 3 | 3 |
| JDR | Staple, Fixation, Bone | 3 | 3 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| FRG | Wrap, Sterilization | 2 | 2 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| DWJ | System, Thermal Regulating | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
Plus 10 more product codes.
Review panels
- General Hospital (10)
- Anesthesiology (7)
- Orthopedic (7)
- Cardiovascular (4)
- General and Plastic Surgery (2)
- Obstetrics and Gynecology (1)
Most recent Medline Industries, LP 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 |
21 earlier clearances. See the full list in Caduvo.
Recalls
551 product recalls in 66 recall events; 551 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medline Industries, LP (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 Industries, Inc. (237 510(k)s)
- Medline (11 510(k)s)
- Medline Industires, Inc. (5 510(k)s)
- Medline Industires, LP (1 510(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, LP?
FDA lists 31 510(k) clearances under the applicant name “Medline Industries, LP” (first 2022, latest 2026), across 20 product codes in 6 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, LP?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medline Industries, LP is 159 days. Since 2017: 159 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medline Industries, LP?
The most frequent FDA product codes under this applicant name are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 3); FYA (Gown, Surgical, 3); JDR (Staple, Fixation, Bone, 3).
Next steps
- See all 31 Medline Industries, LP clearances with predicates and recalls
- Run predicate analysis for product code BTT, Medline Industries, LP'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.