Hudson RCI Dri-Tech Breathing Circuits +6 more— 510(k) K234032

Clearance details

Device name as filed

Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line

Applicant

Medline Industries, LP

Product code

Code BZE

Device class

Class 2

Regulation

21 CFR 868.5270

Advisory panel

Anesthesiology

Date received

2023-12-20

Decision date

2024-06-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Northfiled, IL, US

• K252066 — inspired Heated Breathing Circuit (510-008) +3 more2026-06-18
• 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)2026-03-25
• K243244 — Heated Breathing Tube2025-07-25
• K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)2024-08-02
• K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)2023-06-14

• K253526 — NAMIC Dilator and Sheath2026-07-29
• K254287 — Medline Reusable Blood Pressure Cuff2026-06-22
• K251687 — Konig Bell Circumcision Clamp2026-02-25
• K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)2025-11-20
• K250345 — Medline Bag Decanter2025-10-24

Death

4

Malfunction

910

Other

1

Total

915

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →