# K063735: Presym TRCG Tracheocardiogram, Model 112

- Pathway: 510(k) (Traditional)
- Applicant: Presym, Inc.
- Decided: Sep 19, 2007 after 275 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vital Science Quantascope Model 103: named in the summary without a submission number
- (no number) Respironics Actiheart: named in the summary without a submission number
- (no number) VivoMetrics Lifeshirt: named in the summary without a submission number

## Indications for use
The Presym TrCG (Tracheocardiogram) is a non-invasive device intended to measure acceleration (displacement over time 2 ) of the trachea. The trachea is mechanically linked to the heart and therefore its movement is directly related to that of the heart. The TrCG displays are shown with the patient's ECG (electrocardiograph) and presented for the physician's consideration. There are no set alarms or preset force limits.

Source page: https://510kreport.com/device/K063735
Methodology: https://510kreport.com/methodology