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)— 510(k) K253322
Substantially EquivalentMedline Industries, LP
FDA 510(k) clearance K253322 for 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), Substantially Equivalent on 2026-03-25. Applicant: Medline Industries, LP. Device class: 2.
Summary
Medline Industries' Hudson RCI® Infant Dri-TechTM Breathing Circuits are filed under BZE, breathing system heaters with or without a controller (not humidifiers or nebulizers). The name lists seven items, from HUD99060 (Dri-Tech with 78 Infant Circuit) to HUD1631 (Infant Wye Connector with Swivel).
Class II, 21 CFR 868.5270. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Medline Industries filed from Northfiled, Illinois, as the record spells the city. Review took 176 calendar days (September 30, 2025 to March 25, 2026).
Clearance details
- Applicant
- Medline Industries, LP
- Product code
- Product code BZE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5270
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
Recent devices under product code BZE
view all- K252066 — inspired Heated Breathing Circuit (510-008) +3 more
- K243244 — Heated Breathing Tube
- K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
- K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
More clearances from Medline Industries, LP
view allAdverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.