K201404 is an FDA 510(k) clearance for the Passio Pump Drainage System. This device is classified as a Apparatus, Suction, Patient Care (Class II - Special Controls, product code DWM).
Submitted by Bearpac Medical (Moultonborough, US). The FDA issued a Cleared decision on November 20, 2020, 176 days after receiving the submission on May 28, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K201404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2020 |
| Decision Date | November 20, 2020 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | DWM - Apparatus, Suction, Patient Care |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5050 |