510(k) · Cleared

Cleared

Ambu® Virobac II® Exhalation Filter

K251583510(k) TraditionalCleared Apr 30, 2026342-day reviewClass II21 CFR 868.5260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ambu A/S · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Apr 30, 2026 as substantially equivalent to K954490 (Mercury Medical, 1996) after a 342-day review. Its family tree reaches back 2 generations to 1985.

Decided: Apr 30, 2026
Review: 342 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K851070 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK851070 Resp-Bac Bacteria FilterMedicomp, Inc. · 1985
1 generation backK954490 Mercury Medical CPR Bag Exhalation FilterMercury Medical · 1996
This deviceK251583 Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K851070	Resp-Bac Bacteria Filter	Medicomp, Inc.	1985	—
−1	K954490	Mercury Medical CPR Bag Exhalation Filter	Mercury Medical	1996	—
0 (this device)	K251583	Ambu® Virobac II® Exhalation Filter	Ambu A/S	2026	—

FIG. 1 — Lineage of K251583, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CAH device

#1 K252643 Iso-Gard Filter Straight; Humid-Vent Filter…score 11.3 · 1 generation · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K954490	Mercury Medical CPR Bag Exhalation Filter Summary page 5 …Traditional Predicate Device Trade Name: Mercury Medical CPR Bag Exhalation Filter 510(k) Number: K954490 This predicate has not been subject to a design-related recall,…	Mercury Medical	1996	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 41 years and passes through 3 companies; a new generation was cleared every 29.6 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All CAH devices

CAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · CAH

2in 2024

2007high 5 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAH

237in 2023

2007high 281 (2011) · low 111 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAH

1in 2025

2007high 6 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · CAH

77in 2025

2007high 98 (2014) · low 9 (2011)2025

MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	32
2008	1	—	0	27
2009	4	111	0	18
2010	5	216	2	40
2011	3	281	0	9
2012	3	212	0	16
2013	1	—	1	47
2014	4	250	1	98
2015	2	—	0	51
2016	0	—	0	34
2017	1	—	1	29
2018	0	—	0	33
2019	2	—	0	30
2020	2	—	0	33
2021	2	—	0	56
2022	3	204	6 (6)	67
2023	3	237	0	40
2024	2	—	0	51
2025	0	—	1 (1)	77
2026	2	—	0	—

What is it indicated for?

The Virobac II® Exhalation Filter is a viral/bacterial filter intended for use when the care provider desires to prevent the transmission of viruses or bacteria from patients receiving respiratory support.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K251583 · printed Nov 4, 2026

Cite this page

510(k) Report. “K251583: Ambu® Virobac II® Exhalation Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251583

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026