# K040194: Compumedics Summit IP

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics USA, Ltd.
- Decided: Apr 23, 2004 after 86 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000068 (2000). 4 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013905: Modification EZ-1 System Repiratory Sensors, Pro-Tech Services, Inc. (2002) Summary page 1.
- K021176: Compumedics Somte System, Compumedics Limited (2003) Summary page 1.

## Most influential descendants
- K043132: Universal Xacttrace (2004), 10 descendants of its own
- K090273: Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100 (2009), 7 descendants of its own
- K151940: Thora-3Di, Model T-01 (2016), 3 descendants of its own
- K242001: Philips VSC-MEDlib (2025), 2 descendants of its own
- K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (2025), 1 descendant of its own

## Indications for use
The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The Summit IP is only to be used under the direction and supervision of a physician. The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The Summit IP unit is not intended for use on infant or pediatric patients

Source page: https://510kreport.com/device/K040194
Methodology: https://510kreport.com/methodology