K201026 is an FDA 510(k) clearance for the sOLVe Tube. This device is classified as a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II - Special Controls, product code CBI).
Submitted by Hytek Medical, Inc. (Northridge, US). The FDA issued a Cleared decision on August 10, 2021, 477 days after receiving the submission on April 20, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5740.
| 510(k) Number | K201026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2020 |
| Decision Date | August 10, 2021 |
| Days to Decision | 477 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBI - Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5740 |