Hudson RCI Triflo II Incentive Deep Breathing Exerciser
FDA 510(k) K220565 · Medline Industries, Inc.
510(k) numberK220565
Submission
- Device name
- Hudson RCI Triflo II Incentive Deep Breathing Exerciser
- Applicant
- Medline Industries, Inc.
Northfield, IL, US - Received
- February 28, 2022
- Decision date
- October 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | 07/02/2025SE |
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Questions and answers
When was Hudson RCI Triflo II Incentive Deep Breathing Exerciser cleared by the FDA?
Hudson RCI Triflo II Incentive Deep Breathing Exerciser (K220565) received a 510(k) decision of Substantially Equivalent on October 25, 2022, 239 days after the submission was received.
What is the product code of K220565?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.