# K132709: VR Medical Heat and Moisture Exchanger and Filter

- Pathway: 510(k) (Traditional)
- Applicant: Vr Medical
- Decided: Jul 30, 2014 after 335 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941381 (1994). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031653: Datex-Ohmeda Hmef 750, Datex-Ohmeda (2003) Summary page 1.
- K023641: Datex-Ohmeda Hmef Mini, Datex-Ohmeda (2002) Summary page 1.
- K072002: Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55, Draeger Medical AG & Co. KG (2008) Summary page 1.
- K013089: Ems Hepa Filter and Hme Combinations, Engineered Medical Systems (2002) Summary page 1.

## Most influential descendants
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K132709
Methodology: https://510kreport.com/methodology