510(k) · Cleared

Cleared

VR Medical Heat and Moisture Exchanger and Filter

K132709510(k) TraditionalCleared Jul 30, 2014335-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

Vr Medical · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Jul 30, 2014 as substantially equivalent to K031653 (Datex-Ohmeda, 2003) and 3 other predicates after a 335-day review. Its family tree reaches back 6 generations to 1994. 2 of the 21 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Jul 30, 2014
Review: 335 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K941381 (1994). 19 ancestors in all, the oldest K881657 (1988). 1 later device descends from it, 1 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
5 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
4 generations backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
3 generations backK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
2 generations backK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
1 generation backK072002 Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Recalled (Class I)
This deviceK132709 VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014
Descendant · cites it directly · 0 of its ownK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Recalled (Class I)

Class I recalls in this family

K072002 Filter Carestar 30; Filter Safestar 55…direct predicate · 2008
K221836 Filter CareStar Plus, Filter SafeStar Plus…cites it directly · 2022

Most influential descendants

Showing 1 of 1 · See all

K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K941381	Hygrobac,S Hygroboy and Hygrobaby	Mallinckrodt Medical	1994	1
−5	K013089	Ems Hepa Filter and Hme Combinations	Engineered Medical Systems	2002	—
−4	K021265	Datex-Ohmeda Hmef 500	Datex-Ohmeda	2002	—
−3	K023641	Datex-Ohmeda Hmef Mini	Datex-Ohmeda	2002	—
−2	K030990	Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior	Datex-Ohmeda	2003	—
−1	K072002	Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55	Draeger Medical AG & Co. KG	2008	Class I
0 (this device)	K132709	VR Medical Heat and Moisture Exchanger and Filter	Vr Medical	2014	—
+1	K221836	Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus	Drägerwerk AG & Co. KGaA	2022	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1994	3	0
1995	1	0
1996	1	0
2001	3	0
2002	2	0
2003	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	1

FIG. 1 — Lineage of K132709, 1994–2022Source: 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.

2 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

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What was it cleared against? (4)

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
*	K031653	Datex-Ohmeda Hmef 750 Summary page 1 …Breathing Circuit Bacterial Filter Classification Reference: 21 CFR 868.5260 Product Code: CAM Predicate Devices: Datex- Obmeda H-MEF 750 (K03 1653) Datex- Obmeda 1-IMEF Mini (K(023641) Drager Medical Breathing Circuit Bacterial…	Datex-Ohmeda	2003	—
*	K023641	Datex-Ohmeda Hmef Mini Summary page 1 …nce: 21 CFR 868.5260 Product Code: CAM Predicate Devices: Datex- Obmeda H-MEF 750 (K03 1653) Datex- Obmeda 1-IMEF Mini (K(023641) Drager Medical Breathing Circuit Bacterial Filter (K072002) Engineering Medical…	Datex-Ohmeda	2002	—
*	K072002	Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 Summary page 1 …atex- Obmeda H-MEF 750 (K03 1653) Datex- Obmeda 1-IMEF Mini (K(023641) Drager Medical Breathing Circuit Bacterial Filter (K072002) Engineering Medical Systems HEPA Filteri/ HME (1(013089) Indication for Use: The Heat and Moisture Exch…	Draeger Medical AG & Co. KG	2008	Class I
*	K013089	Ems Hepa Filter and Hme Combinations Summary page 1 …i (K(023641) Drager Medical Breathing Circuit Bacterial Filter (K072002) Engineering Medical Systems HEPA Filteri/ HME (1(013089) Indication for Use: The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who req…	Engineered Medical Systems	2002	—

Also cleared against K031653: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K221836	Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus Class I	Drägerwerk AG & Co. KGaA	2022	0

Has anything in its family been recalled? (2 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
4 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K221836 (Drägerwerk AG & Co. KGaA, 2022) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K031653.

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. 2014, 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 Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

The Heat and Moisture Exchanger and Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132709 · printed Nov 5, 2026

Cite this page

510(k) Report. “K132709: VR Medical Heat and Moisture Exchanger and Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132709

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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