# K120052: Cvinsight

- Pathway: 510(k) (Traditional)
- Applicant: Intelomed, Inc.
- Decided: Sep 4, 2012 after 242 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910772 (1991). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102350: Pulse Oximeter, Nonin Medical, Inc. (2010) Summary page 1.
- K040589: Modification to Avant 9600 Pulse Oximeter, Nonin Medical, Inc. (2004) Summary page 1.
- K960884: Tele Trens TM 10, Life Sensing Instrument Company, Inc. (1997) Summary page 1.
- K853124: Novametrix Pulse Oximeter, Model 500, Novametrix Medical Systems, Inc. (1985) Summary page 1.

## Indications for use
The CVlnsight system is comprised of a pulse oximeter and a software application installed and operating on a personal computer. The pulse oximeter device is indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients who are well or poorly perfused. The intended use environments are Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies. CVlnsight measures, displays, and stores functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate, and provides alarm functionality for these parameters. Additionally, CVlnsight provides a utility for recording trends of pulse rate, SpO2, and the percentage of change from a user-defined baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

Source page: https://510kreport.com/device/K120052
Methodology: https://510kreport.com/methodology