K050166 is an FDA 510(k) clearance for the PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT. This device is classified as a Needle, Emergency Airway (Class II - Special Controls, product code BWC).
Submitted by Smiths Medical (Hythe, Kent, GB). The FDA issued a Cleared decision on May 26, 2005, 120 days after receiving the submission on January 26, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5090.
| 510(k) Number | K050166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2005 |
| Decision Date | May 26, 2005 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BWC - Needle, Emergency Airway |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5090 |