Medline Industries, LP · Class II · Cleared Mar 25, 2026
| K-number | K253322 |
| Device name | 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) |
| Applicant | Medline Industries, LP |
| Product code | BZE |
| Device class | Class II |
| Decision date | Mar 25, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 868.5270 |
The Hudson RCI Infant Dri-Tech Breathing Circuits are heated breathing circuits designed for neonatal, infant, and pediatric patients weighing 32 kg or less in professional healthcare environments. They serve as a conduit for warmed and humidified respiratory gases between a patient and a ventilator, featuring heated wires to maintain patient temperature and minimize condensation. The circuits are available in single limb and dual limb configurations with various length options and compatible accessories.
The proposed device is identical to the predicate in intended use, mode of action, circuit configurations (single and dual limb with heated wire), power source (humidifier-controlled), and compliance/resistance to flow characteristics. Key differences include a shorter useful life (14 days versus 30 days), restriction to professional healthcare environments only (versus home and professional), and limitation to pediatric patients 32 kg or less (versus neonates to adults). The device is tested to the most current standard revisions (ISO 80601-2-74:2017 versus older versions used for the predicate).
BS EN ISO 5367:2014 (breathing sets and connectors), BS EN ISO 5356-1:2015 (conical connectors), BS EN ISO 80601-2-74:2017 (heated respiratory gas humidifiers), BS EN ISO 10993-1:2018 (biocompatibility), BS EN ISO 18562-1:2024 (breathing gas pathway biocompatibility), BS IEC 60601-1:2020 (electrical safety), BS IEC 60601-1-2:2020 (electromagnetic compatibility), and IEC 62366-1:2015 (human factors).
The Hudson RCI Dri-Tech Breathing Circuits are substantially equivalent to the Hybernite RT predicate device because both share identical intended use, operating principles, circuit configurations, and technological characteristics. The differences in patient population (exclusion of adults), environment of use (professional healthcare only), and useful life (14 versus 30 days) do not raise additional safety or effectiveness concerns, as the predicate is cleared for broader populations and environments, and a shorter useful life is less challenging to support. The device meets or exceeds applicable standards through non-clinical testing including biocompatibility, performance, electrical safety, and human factors evaluation.
View the full FDA submission: accessdata.fda.gov