K253322
- 510(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 IL · US
- Product code
- BZE — Heater, Breathing System W/Wo Controller (Not Humidi
- Decision date
- 2026-03-25
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K253322.pdf
Official FDA record: K253322
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.