K190213 is an FDA 510(k) clearance for the Yikang Endotracheal Tube. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Jiangxi Yikang Medical Instrument Group Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on September 6, 2019, 214 days after receiving the submission on February 4, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K190213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2019 |
| Decision Date | September 06, 2019 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTR - Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |