510(k) · Cleared
ClearedNICOM
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 Nov 12, 2004 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 48 later devices descend from it.
- Decided
- Nov 12, 2004
- Review
- 95 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 2 citing it directly.
- This deviceK042144 NICOMCheetah Medical, Inc. · 2004
- Descendant · cites it directly · 46 of its ownK072662 Cheetah Reliant, Cheetah ActiveCheetah Medical, Inc. · 2008
- Descendant · 2 generations on · 45 of its ownK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
- Descendant · cites it directly · 36 of its ownK071631 Nicom ElectrodesCheetah Medical, Inc. · 2008
- Descendant · 2 generations on · 35 of its ownK101487 Cheetah Nicom SystemCheetah Medical, Inc. · 2010
- Descendant · 3 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K072662Cheetah Reliant, Cheetah ActiveCheetah Medical, Inc. · 2008 · cites it directly46descendants
- K083093Cheetah ReliantCheetah Medical, Inc. · 2008 · 2 generations on45descendants
- K071631Nicom ElectrodesCheetah Medical, Inc. · 2008 · cites it directly36descendants
- K101487Cheetah Nicom SystemCheetah Medical, Inc. · 2010 · 2 generations on35descendants
- K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042144 | NICOM | Cheetah Medical, Inc. | 2004 | — |
| +1 | K072662 | Cheetah Reliant, Cheetah Active | Cheetah Medical, Inc. | 2008 | — |
| +2 | K083093 | Cheetah Reliant | Cheetah Medical, Inc. | 2008 | 1 |
| +1 | K071631 | Nicom Electrodes | Cheetah Medical, Inc. | 2008 | — |
| +2 | K101487 | Cheetah Nicom System | Cheetah Medical, Inc. | 2010 | — |
| +3 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (48)
See all 482 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072662 (Cheetah Medical, Inc., 2008) has gone furthest, with 46 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.
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].
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042144: NICOM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042144
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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