Clearance Summary
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) received FDA 510(k) clearance under submission number K253322, sponsored by Medline Industries, LP. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-03-25.
- Submission: K253322
- Applicant / Sponsor: Medline Industries, LP
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5270
- Decision date: 2026-03-25
Classification & Regulation
This clearance is catalogued under FDA product code BZE and 21 CFR 868.5270, within the Anesthesiology review panel as a Class II device.