K234032 is an FDA 510(k) clearance for the Hudson RCI Dri-Tech Breathing Circuits. 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 June 4, 2024, 167 days after receiving the submission on December 20, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K234032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2023 |
| Decision Date | June 04, 2024 |
| Days to Decision | 167 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 |