# K030656: Envan Heart Rate Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Envan, LLC
- Decided: Apr 8, 2003 after 36 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
Longest line of descent: 4 generations back to K962603 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022435: 507EL Vital Signs Monitor, Criticare Systems, Inc. (2002) Summary page 2.
- K992340: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-PE, Masimo Corp. (1999) Summary page 2.

## Indications for use
The EnViin Heart Rate Monitor is indicated for use to measure the heart rate of patients who require routine periodic vital signs monitoring. It is intended to provide heart rate information on a wristwatch display for interpretation by a healthcare professional in a hospital, outpatient, or ambulatory care setting. It is neither designed nor intended for use in the place of cardiac (electrocardiograph) monitoring. The EnViin Heart Rate Monitor is not suitable for use in emergency rooms, intensive care or cardlac care units, or operating room or post anesthesia units where cardiac monitors, pacemakers and other types of electrical or electronic medical devices are in use. These devices may interfere with the operation of the EnViin Heart Rate Monitor.

Source page: https://510kreport.com/device/K030656
Methodology: https://510kreport.com/methodology