K253322 is an FDA 510(k) clearance for the 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). This device is classified as a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II - Special Controls, product code BZE).
Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on March 25, 2026, 176 days after receiving the submission on September 30, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K253322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | March 25, 2026 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZE - Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5270 |