510(k) · Cleared
Recalled · Class III · 2022Cheetah Reliant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cheetah Medical, Inc. · DSB Plethysmograph, Impedance
Cleared on Dec 15, 2008 as substantially equivalent to K072662 (Cheetah Medical, Inc., 2008) and 2 other predicates after a 59-day review. Its family tree reaches back 6 generations to 1991. 45 later devices descend from it. It has been recalled once.
- Decided
- Dec 15, 2008
- Review
- 59 days
- Class
- Class II
- Product code
- DSB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K903134 (1991). 10 ancestors in all. 45 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 5 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 4 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 3 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 2 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 1 generation backK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
- This deviceK083093 Cheetah ReliantCheetah 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 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · 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 |
|---|---|---|---|---|---|
| −6 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −5 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −4 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −3 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −2 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −1 | K081590 | YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| 0 (this device) | K083093 | Cheetah Reliant | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 DSB? 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 DSB device
- #1 K232089 SOZO Proscore 14.6 · 9 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 |
|---|---|---|---|
| * | K072662 | Cheetah Reliant, Cheetah ActiveSummary page 1…CFR 870.2770/DSB - Impedance plethysmograph 21 CFR 870.1130/DXN - Non-invasive blood pressure monitor Predicate Devices: K072662 - Cheetah Reliant K010164 - GE Medical Systems ICG Module K081590 - Ya Horng Arm Type Digital… | 2008 |
| * | K010164 | Icg ModuleSummary page 1…21 CFR 870.1130/DXN - Non-invasive blood pressure monitor Predicate Devices: K072662 - Cheetah Reliant K010164 - GE Medical Systems ICG Module K081590 - Ya Horng Arm Type Digital Blood Pressure Monitor Device Descript… | 2001 |
| * | K081590 | YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Summary page 1…ve blood pressure monitor Predicate Devices: K072662 - Cheetah Reliant K010164 - GE Medical Systems ICG Module K081590 - Ya Horng Arm Type Digital Blood Pressure Monitor Device Description: The Cheetah Reliant with NIPB funct… | 2008 |
What descends from it? (45)
See all 453 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2022 | Class III | Z-1817-2022 | Process control | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 10 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 DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 2025
MAUDE reports naming product code DSB, 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 | 2 | — | 0 | 0 |
| 2008 | 6 | 90 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 266 | 0 | 2 |
| 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) and heart rate. In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already…
Read the full statement (131 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) and heart rate. 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), electrical impedance of the chest cavity (ZO) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083093 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083093: Cheetah Reliant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083093
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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