510(k) · Cleared
ClearedEnvan Heart Rate Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envan, LLC · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Apr 8, 2003 as substantially equivalent to K022435 (Criticare Systems, Inc., 2002) and 1 other predicate after a 36-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Apr 8, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962603 (1997). 10 ancestors in all, the oldest K923682 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK992340 Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp. · 1999 · Recalled
- This deviceK030656 Envan Heart Rate MonitorEnvan, LLC · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop… | Masimo Corp. | 1999 | 1 |
| 0 (this device) | K030656 | Envan Heart Rate Monitor | Envan, LLC | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022435 | 507EL Vital Signs MonitorSummary page 2…d every few seconds, to assure an accurate measurement of heart rate. Basis for Substantial Equivalence Predicate Devices: Criticare Systems Vital Signs Monitor (K022435) and Masimo SET@ Radical Pulse Oximeter (K992340) The EnVan Heart Rate Monitor has indications for use equivalent to th… | 2002 |
| * | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Summary page 2…t of heart rate. Basis for Substantial Equivalence Predicate Devices: Criticare Systems Vital Signs Monitor (K022435) and Masimo SET@ Radical Pulse Oximeter (K992340) The EnVan Heart Rate Monitor has indications for use equivalent to those for the heart rate monitoring capabilities of… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K022435.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
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…
Read the full statement (119 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030656: Envan Heart Rate Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030656
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026