# K141087: Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled Hmef

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical Incorporated
- Decided: Feb 12, 2015 after 290 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: 1 generation back to K941381 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941381: Hygrobac,S Hygroboy and Hygrobaby, Mallinckrodt Medical (1994) Summary page 4.

## Indications for use
The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to < 30 days. The recommended pediatric weight range is 11 kg to 35 kg. The recommended tidal volume is 75 to 250 ml.

Source page: https://510kreport.com/device/K141087
Methodology: https://510kreport.com/methodology