K220565 is an FDA 510(k) clearance for the Hudson RCI Triflo II Incentive Deep Breathing Exerciser. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on October 25, 2022, 239 days after receiving the submission on February 28, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K220565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2022 |
| Decision Date | October 25, 2022 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BWF — Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |