# K991644: Microgas 7650 Transcutaneous Monitor

- Pathway: 510(k) (Special)
- Applicant: Linde Medical Sensors AG
- Decided: May 21, 1999 after 8 days
- Product code: KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.2500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P810037: Kontron Cutaneous PCO2 Monitor, Kontron Cardiovascular. FDA lists this PMA only through its supplements; the earliest we hold is P810037/S001 (Sep 16, 1982). Summary page 1.

## Most influential descendants
- K041548: Sentec Digital Monitor Model #SDM (2004), 5 descendants of its own
- K071672: Sentec Digital Monitoring System (2007), 4 descendants of its own
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (2010), 3 descendants of its own
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (2015), 1 descendant of its own
- K232516: Sentec Digital Monitoring System (SDMS) tCOM+ (2024), 0 descendants of its own

## Indications for use
The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.

Source page: https://510kreport.com/device/K991644
Methodology: https://510kreport.com/methodology