Ambu® Virobac II® Exhalation Filter— 510(k) K251583
Substantially EquivalentAmbu A/S
FDA 510(k) clearance K251583 for Ambu® Virobac II® Exhalation Filter, Substantially Equivalent on 2026-04-30. Applicant: Ambu A/S. Device class: 2.
Summary
The Ambu Virobac II Exhalation Filter, from Ambu A/S, is filed under product code CAH (Filter, Bacterial, Breathing-Circuit).
Class II, 21 CFR 868.5260. The General Hospital review panel handled it as a Traditional 510(k), though the record lists Anesthesiology as the classification panel.
Ambu filed from Ballerup, Denmark. The record shows 342 calendar days from receipt to decision (May 23, 2025 to April 30, 2026).
Clearance details
- Applicant
- Ambu A/S
- Product code
- Product code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ballerup, DK
Recent devices under product code CAH
view all- K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
- K241339 — Besmed Bacterial Filter and HMEF
- K222917 — Breathing circuit bacterial/viral filter
- K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
- K223258 — TNI Clear-Guard 3 angled breathing filter (1545020)
More clearances from Ambu A/S
view all- K260309 — Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- K261400 — Ambu® aScope Gastro; Ambu® aScope Gastro Large
- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
- K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.