510(k) · Cleared
ClearedCheetah Nicom System
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 Jul 2, 2010 as substantially equivalent to K071631 (Cheetah Medical, Inc., 2008) and 1 other predicate after a 35-day review. Its family tree reaches back 7 generations to 1991. 35 later devices descend from it.
- Decided
- Jul 2, 2010
- Review
- 35 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K903134 (1991). 13 ancestors in all. 35 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 6 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 5 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 4 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 3 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 2 generations backK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
- 1 generation backK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
- This deviceK101487 Cheetah Nicom SystemCheetah Medical, Inc. · 2010
- Descendant · cites it directly · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- Descendant · 2 generations on · 27 of its ownK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- Descendant · 3 generations on · 18 of its ownK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
- Descendant · 3 generations on · 15 of its ownK211465 HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced…Edwards Lfesciences · 2021
- Descendant · 4 generations on · 14 of its ownK213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2022
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · cites it directly34descendants
- K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · 2 generations on27descendants
- K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC · 2021 · 3 generations on18descendants
- K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences · 2021 · 3 generations on15descendants
- K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC · 2022 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −6 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −5 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −4 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −3 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −2 | K081590 | YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −1 | K083093 | Cheetah Reliant | Cheetah Medical, Inc. | 2008 | 1 |
| 0 (this device) | K101487 | Cheetah Nicom System | Cheetah Medical, Inc. | 2010 | — |
| +1 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
| +2 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 1 |
| +3 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension… | Edwards Lifesciences, LLC | 2021 | — |
| +3 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring… | Edwards Lfesciences | 2021 | — |
| +4 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K071631 | Nicom ElectrodesSummary page 1…DRX Devices to which substantial equivalence isclaimed: 510(k) number Trade or propriety name Submitter K071631 NICOM electrodes Cheetah-Medical Inc. K083 093 Cheetah Reliant… | 2008 |
| * | K083093 | Cheetah Reliant Our reading of the summary gave K082093, FDA’s number for Bullseye Biliary Stent System (Squareone). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cheetah Reliant”. | 2008 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | 2019 | 34 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K190205 (Edwards Lifesciences, LLC, 2019) has gone furthest, with 34 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. 2010, 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 Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the…
Read the full statement (140 words)
The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TEC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.
The alternative NICOM Sensors are disposable electrodes, used in conjunction with the Cheetah Medical NICOM signal processing product line.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101487: Cheetah Nicom System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101487
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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