# Medline Industries, Inc.

- Location (FDA's records): Mundelein, IL
- FDA decisions: 269 (1977–2026): 268 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Medline Industries, Inc. (238); Medline Industries, LP (31)
- Product codes: FYA (16), LZA (13), KGO (12), FRG (11), FRO (9), INI (9), LYY (8), GEI (8), KKX (6), HRS (6), KNT (5), KOD (5)
- 510(k) review time since 2016: median 156 days, against 131 for FDA's reviews in the same codes and years (37 of 87 faster)
- Predicates its devices cite: 125 (34 its own); citations of its devices by later devices: 108 (34 its own)
- Recalls linked to its devices: 82 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 11 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Fisher & Paykel Healthcare, Ltd.: 3 (https://510kreport.com/company/fisher-paykel-healthcare)
- Kimberly-Clark Corp.: 3 (https://510kreport.com/company/kimberly-clark)
- B.Braun Medical, Inc.: 3 (https://510kreport.com/company/b-braun-medical)
- Tyco Healthcare: 2 (https://510kreport.com/company/tyco-healthcare)
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Plastiflex Group NV: 2 (https://510kreport.com/company/plastiflex-group)

## Firms that cite its devices most
- Medline Industires, Inc.: 3 (https://510kreport.com/company/medline-industires)
- Yadu Medical (Henan) Co., Ltd.: 3 (https://510kreport.com/company/yadu-medical-henan)
- Bionova Medical, Inc.: 2 (https://510kreport.com/company/bionova-medical)
- Winner Medical Co., Ltd.: 2 (https://510kreport.com/company/winner-medical)
- Exact Medical Manufacturing, Inc.: 2 (https://510kreport.com/company/exact-medical-manufacturing)
- Huizhou Foryou Medical Devices Co., Ltd.: 2 (https://510kreport.com/company/huizhou-foryou-medical-devices)
- International Medsurg Connection: 2 (https://510kreport.com/company/international-medsurg-connection)
- Osprey Medical, Inc.: 2 (https://510kreport.com/company/osprey-medical)

## Its most-cited devices
- K130319: Medline Cannulated Screw (2013), cited by 9
- K151235: Medline Foot Plates and Screws (2015), cited by 6
- K190950: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) (2019), cited by 5
- K964142: Medline Disposable Surgical Drapes and Gowns (1997), cited by 5
- K113583: Curad Antibacterial Bandage (2012), cited by 5
- K071552: Puracol Plus AG Collagen Microscaffold Wound Dressing (2008), cited by 4

## Recent decisions
- K253526: NAMIC Dilator and Sheath (Jul 29, 2026)
- K254287: Medline Reusable Blood Pressure Cuff (Jun 22, 2026)
- 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) (Mar 25, 2026)
- K251687: Konig Bell Circumcision Clamp (Feb 25, 2026)
- K253070: Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (Nov 20, 2025)
- K250345: Medline Bag Decanter (Oct 24, 2025)
- K250312: Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (Jul 2, 2025)
- K243888: Medline UNITE®  REFLEX®  Hybrid Nitinol Implant System (Apr 11, 2025)

Source page: https://510kreport.com/company/medline-industries