510(k) · Cleared

Cleared

70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral Filter

K091185510(k) TraditionalCleared Jul 24, 200992-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

Hsiner Co., Ltd. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Jul 24, 2009 as substantially equivalent to K961914 (Hudson Respiratory Care, Inc., 1996) and 1 other predicate after a 92-day review. Its family tree reaches back 2 generations to 1979.

Decided: Jul 24, 2009
Review: 92 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K792097 (1979). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK792097 Dryden Bacteria FilterDryden Corp. · 1979
1 generation backK961914 Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996
This deviceK091185 70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral FilterHsiner Co., Ltd. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K792097	Dryden Bacteria Filter	Dryden Corp.	1979	—
−1	K961914	Bacteria/Viral Filter	Hudson Respiratory Care, Inc.	1996	—
0 (this device)	K091185	70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral Filter	Hsiner Co., Ltd.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K091185, 1979–2009Source: 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 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · 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? (2)

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
*	K961914	Bacteria/Viral Filter Summary page 1 …: CAH , Regulation #: 868.5260 Device Class: 2 1.3. Substantially equivalent to: - Hudson RCI Bacterial/Vial Filter (961914) - Gibeck Humid Vent filter Compact (K964382) 1.4. Description of the device The BFE/VFE filters, manufactured by…	Hudson Respiratory Care, Inc.	1996	—
*	K964382	Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402) Summary page 1 …Device Class: 2 1.3. Substantially equivalent to: - Hudson RCI Bacterial/Vial Filter (961914) - Gibeck Humid Vent filter Compact (K964382) 1.4. Description of the device The BFE/VFE filters, manufactured by Hsiner, 1TD are disposable, single-use barrier type, bi-…	Gibeck, Inc.	1997	—

Also cleared against K961914: 3 other devices →

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 30 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
None of the 3 ancestors has a recall.
3 other devices also cite its predicate K961914.

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. 2009, 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?

Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091185 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091185: 70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091185

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026