K211286 is an FDA 510(k) clearance for the Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Pall Corporation (Port Washington, US). The FDA issued a Cleared decision on November 16, 2021, 203 days after receiving the submission on April 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K211286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2021 |
| Decision Date | November 16, 2021 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |