510(k) · Cleared
ClearedNicom Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cheetah Medical, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jan 18, 2008 as substantially equivalent to K000664 (Baxter Healthcare Corp, 2000) and 1 other predicate after a 218-day review. Its family tree reaches back 1 generation to 2000. 36 later devices descend from it.
- Decided
- Jan 18, 2008
- Review
- 218 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000664 (2000). 2 ancestors in all. 36 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000664 Vigilance Cco/Cedv & Vigilance Cco/SVO2/Cedv MonitorsBaxter Healthcare Corp · 2000
- This deviceK071631 Nicom ElectrodesCheetah Medical, Inc. · 2008
- Descendant · cites it directly · 35 of its ownK101487 Cheetah Nicom SystemCheetah Medical, Inc. · 2010
- Descendant · 2 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- Descendant · 3 generations on · 27 of its ownK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- Descendant · 4 generations on · 18 of its ownK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
- Descendant · 4 generations on · 15 of its ownK211465 HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced…Edwards Lfesciences · 2021
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K101487Cheetah Nicom SystemCheetah Medical, Inc. · 2010 · cites it directly35descendants
- K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 2 generations on34descendants
- K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · 3 generations on27descendants
- K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC · 2021 · 4 generations on18descendants
- K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences · 2021 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000664 | Vigilance Cco/Cedv & Vigilance Cco/SVO2/Cedv Monitors | Baxter Healthcare Corp | 2000 | — |
| 0 (this device) | K071631 | Nicom Electrodes | Cheetah Medical, Inc. | 2008 | — |
| +1 | K101487 | Cheetah Nicom System | Cheetah Medical, Inc. | 2010 | — |
| +2 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
| +3 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 1 |
| +4 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension… | Edwards Lifesciences, LLC | 2021 | — |
| +4 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring… | Edwards Lfesciences | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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 DXG? 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 DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K000664 | Vigilance Cco/Cedv & Vigilance Cco/SVO2/Cedv MonitorsSummary page 2…ch substantial equivalence is claimed: The Cheetah NICOM system was found substantially equivalent to the VLIGILANCE CCO/CEDV 7 VIGILANCE CCO/SVO 2/CEDV Monitor (K000664) under K042144. The NICOM Electrodes are substantially equivalent to the electrodes cleared for marketing with the origi… | 2000 |
| * | K042144 | NICOMSummary page 2…equivalence is claimed: The Cheetah NICOM system was found substantially equivalent to the VLIGILANCE CCO/CEDV 7 VIGILANCE CCO/SVO 2/CEDV Monitor (K000664) under K042144. The NICOM Electrodes are substantially equivalent to the electrodes cleared for marketing with the original NICOM Monit… | 2004 |
| * | — | 3M Health Care Red Dot electrodes Named without a submission number |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101487 | Cheetah Nicom System | 2010 | 35 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K101487 (Cheetah Medical, Inc., 2010) has gone furthest, with 35 descendants of its own.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, 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 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of Ltr/Min, and was cleared under K042144.
NICOM Electrodes are disposable electrodes used in conjunction with the NICOM signal processing product line.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071631 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071631: Nicom Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071631
Report an extraction error
Are you the manufacturer?
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