Ambu® Virobac II® Exhalation Filter
FDA 510(k) K251583 · Ambu A/S
510(k) numberK251583
Submission
- Device name
- Ambu® Virobac II® Exhalation Filter
- Applicant
- Ambu A/S
Ballerup, DK - Received
- May 23, 2025
- Decision date
- April 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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Questions and answers
When was Ambu® Virobac II® Exhalation Filter cleared by the FDA?
Ambu® Virobac II® Exhalation Filter (K251583) received a 510(k) decision of Substantially Equivalent on April 30, 2026, 342 days after the submission was received.
What is the product code of K251583?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.