Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medline Industries, LP — Predicate Candidate Screening

31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

159 daysmedian FDA review time
264 days90th percentile
31clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253526NAMIC Dilator and SheathMedline Industries, LP2026-07-292580
K254287Medline Reusable Blood Pressure CuffMedline Industries, LP2026-06-221730
K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 /Medline Industries, LP2026-03-251760
K251687Konig Bell Circumcision ClampMedline Industries, LP2026-02-252680
K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial ArmMedline Industries, LP2025-11-20580
K250345Medline Bag DecanterMedline Industries, LP2025-10-242600
K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; HudMedline Industries, LP2025-07-021490
K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP2025-04-111140
K242844Medline Level 4 Surgical Gown with Breathable SleevesMedline Industries, LP2025-02-261590
K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); MedMedline Industries, LP2024-12-191320
K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP2024-12-191820
K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort FMedline Industries, LP2024-09-272490
K234132Medline Reusable Sterilization WrappersMedline Industries, LP2024-09-172640
K241359Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP2024-08-02800
K234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech AdMedline Industries, LP2024-06-041670
K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® BMedline Industries, LP2024-03-261810
K233526Medline Open-back Level 3 Protective GownMedline Industries, LP2024-03-051250
K230235Medline Luer Lock SyringesMedline Industries, LP2024-02-163850
K231058Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP2024-01-042660
K231211Medline ComfortTemp Patient Warming SystemMedline Industries, LP2023-12-012170
K230602Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP2023-10-312420
K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP2023-10-19300
K231907Medline Safety Insulin and TB SyringesMedline Industries, LP2023-10-181110
K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP2023-08-09430
K223236Medline Surgical Face Mask and Medline Procedural Face MaskMedline Industries, LP2023-03-241560
K220365Gemini Sterilization WrapMedline Industries, LP2022-10-062400
K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP2022-09-271390
K220333Medline Orbis LVL 3 Surgical GownMedline Industries, LP2022-05-181030
K214108Medline Orbis Chemo Surgical GownMedline Industries, LP2022-05-061280
K220511Medline UNITE IM Fibula ImplantMedline Industries, LP2022-03-22280
K213567Medline UNITE Calcaneal Fracture Plating SystemMedline Industries, LP2022-03-021130

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