510(k) · Cleared

Cleared

Ems Hepa Filter and Hme Combinations

K013089510(k) TraditionalCleared Mar 14, 2002178-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

Engineered Medical Systems · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Mar 14, 2002 as substantially equivalent to K941676 (Mallinckrodt Medical, 1994) and 5 other predicates after a 178-day review. Its family tree reaches back 1 generation to 1994. 8 of the 46 devices in its family, counting itself, have a Class I recall. 39 later devices descend from it.

Decided: Mar 14, 2002
Review: 178 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K941381 (1994). 6 ancestors in all. 39 later devices descend from it, 5 citing it directly. 8 of the 46 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
This deviceK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
Descendant · cites it directly · 29 of its ownK033008 Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd. · 2004
Descendant · 2 generations on · 22 of its ownK060705 Carina HomeDraeger Medical B.V. · 2006 · Recalled
Descendant · 3 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
Descendant · cites it directly · 11 of its ownK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
Descendant · 4 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2002high 5 (2012) · low 0 (2007)2026

Class I recalls in this family

K072002 Filter Carestar 30; Filter Safestar 55…cites it directly · 2008
K221836 Filter CareStar Plus, Filter SafeStar Plus…2 generations on · 2022
K072885 Carina System, Model 8419350; Carina Basic…3 generations on · 2008
K113053 Bipap a 30 Ventilatory Support System4 generations on · 2012

Most influential descendants

Showing 5 of 39 · See all

K033008Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd. · 2004 · cites it directly29descendants
K060705Carina HomeDraeger Medical B.V. · 2006 · 2 generations on22descendants
K103167Stellar 150Resmed Germany, Inc. · 2011 · 3 generations on20descendants
K021265Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002 · cites it directly11descendants
K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941381	Hygrobac,S Hygroboy and Hygrobaby	Mallinckrodt Medical	1994	1
0 (this device)	K013089	Ems Hepa Filter and Hme Combinations	Engineered Medical Systems	2002	—
+1	K033008	Air Safety Hepa and Non-Hepa Filters	Air Safety, Ltd.	2004	—
+2	K060705	Carina Home	Draeger Medical B.V.	2006	1
+3	K103167	Stellar 150	Resmed Germany, Inc.	2011	—
+1	K021265	Datex-Ohmeda Hmef 500	Datex-Ohmeda	2002	—
+4	K113053	Bipap a 30 Ventilatory Support System	Respironics, Inc.	2012	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
2001	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	2	0
2004	2	0
2005	3	0
2006	1	0
2008	3	2
2009	1	0
2010	1	0
2011	3	0
2012	5	2
2013	2	1
2014	1	0
2016	2	0
2017	1	0
2019	1	1
2021	1	1
2022	2	1
2024	2	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K013089, 1994–2026Source: 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.

8 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (6)

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
*	K941676	Sterivent and Sterivent S Summary page 1 …ilter and HEPA Filter / HME Bacterial / Viral Filter and Heat and Moisture Exchanger Filter, Bacterial, Breathing Circuit, CAH Mallinckrodt Sterivent and Sterivent “S”—K941676 Mallinckrodt — Hygroster — K941585 Mallinckrodt Hygrobac “S” — K941381 ARC Medical Filter - K011212 Allegiance Two Way HEPA —K…	Mallinckrodt Medical	1994	1
*	K941585	Hygroster Summary page 1 …ial / Viral Filter and Heat and Moisture Exchanger Filter, Bacterial, Breathing Circuit, CAH Mallinckrodt Sterivent and Sterivent “S”—K941676 Mallinckrodt — Hygroster — K941585 Mallinckrodt Hygrobac “S” — K941381 ARC Medical Filter - K011212 Allegiance Two Way HEPA —K011132 SIMS Filter — K002201 \|Devi…	Mallinckrodt Medical	1994	—
*	K941381	Hygrobac,S Hygroboy and Hygrobaby Summary page 1 …ure Exchanger Filter, Bacterial, Breathing Circuit, CAH Mallinckrodt Sterivent and Sterivent “S”—K941676 Mallinckrodt — Hygroster — K941585 Mallinckrodt Hygrobac “S” — K941381 ARC Medical Filter - K011212 Allegiance Two Way HEPA —K011132 SIMS Filter — K002201 \|Device Description \| The EMS HEPA Filte…	Mallinckrodt Medical	1994	1
*	K011212	Filterflo H Cleared while this submission was under review Summary page 1 …l, Breathing Circuit, CAH Mallinckrodt Sterivent and Sterivent “S”—K941676 Mallinckrodt — Hygroster — K941585 Mallinckrodt Hygrobac “S” — K941381 ARC Medical Filter - K011212 Allegiance Two Way HEPA —K011132 SIMS Filter — K002201 \|Device Description \| The EMS HEPA Filter and combined HEPA filter / H…	Arc Medical, Inc.	2001	—
*	K011132	Airlife Hepa Filter Summary page 1 …krodt Sterivent and Sterivent “S”—K941676 Mallinckrodt — Hygroster — K941585 Mallinckrodt Hygrobac “S” — K941381 ARC Medical Filter - K011212 Allegiance Two Way HEPA —K011132 SIMS Filter — K002201 \|Device Description \| The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes…	Allegiance Healthcare Corp.	2001	—
*	K002201	Electrostatic Hydrophobic Breathing Filter Summary page 1 …erivent “S”—K941676 Mallinckrodt — Hygroster — K941585 Mallinckrodt Hygrobac “S” — K941381 ARC Medical Filter - K011212 Allegiance Two Way HEPA —K011132 SIMS Filter — K002201 \|Device Description \| The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, rectangul…	Sims Portex, Inc.	2001	—

Also cleared against K941676: 1 other device →

What descends from it? (39)

See all 39

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033008	Air Safety Hepa and Non-Hepa Filters	Air Safety, Ltd.	2004	29
K021265	Datex-Ohmeda Hmef 500	Datex-Ohmeda	2002	11
K072002	Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 Class I	Draeger Medical AG & Co. KG	2008	3
K132709	VR Medical Heat and Moisture Exchanger and Filter	Vr Medical	2014	1
K040712	Air Safety Hepa, Model 3500	Air Safety, Ltd.	2004	0

Has anything in its family been recalled? (8 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
K122715Stellar 150Resmed Germany, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
K193586Vivo 45 LSBreas Medical AB · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

2 of the 6 ancestors have a recall of any class.
Of its descendants, K033008 (Air Safety, Ltd., 2004) has gone furthest, with 29 descendants of its own.
1 other device also cites its predicate K941676.

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.

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?

For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient

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/K013089 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013089: Ems Hepa Filter and Hme Combinations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013089

Report an extraction error

Are you the manufacturer?

Record history

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