510(k) · Cleared
ClearedCheetah 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 Jan 25, 2011 as substantially equivalent to K083093 (Cheetah Medical, Inc., 2008) and 1 other predicate after a 90-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it.
- Decided
- Jan 25, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K903134 (1991). 23 ancestors in all, the oldest K863784 (1986). 1 later device descends 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 deviceK103166 Cheetah ReliantCheetah Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK110645 Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011 · cites it directly0descendants
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) | K103166 | Cheetah Reliant | Cheetah Medical, Inc. | 2011 | — |
| +1 | K110645 | Bio Z Cardio Profile Hemodynamic Monitor | Sonosite,Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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? (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 |
|---|---|---|---|
| * | K083093 | Cheetah ReliantSummary page 1…n-invasive blood pressure monitor 21 CFR 870.2700/DQA- Non-invasive blood oxygen saturation monitor Predicate Devices: K083093 - Cheetah Reliant with NIBP functionality K060576 - NELLCOR /N-600x Oximax pulse oximeter Device Descript… | 2008 |
| * | K060576 | Nellcor Oximax N-600X Pulse OximeterSummary page 1…870.2700/DQA- Non-invasive blood oxygen saturation monitor Predicate Devices: K083093 - Cheetah Reliant with NIBP functionality K060576 - NELLCOR /N-600x Oximax pulse oximeter Device Description: The Cheetah Reliant with oxygen saturation (S… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110645 | Bio Z Cardio Profile Hemodynamic Monitor | 2011 | 0 |
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 20 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K110645 (Sonosite,Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K083093.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 and SpO2 functionalities is a portable, hemodynamic monitoring and non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood…
Read the full statement (210 words)
The Cheetah Reliant with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring and non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). The device displays associated heamodynamic parameters based on calculations with measurements incorporated into the Cheetah Reliant. These parameters are:
* Cardiac Index (CI),
* Stroke Volume (SV),
* Stroke Volume Index (SVI),
* Stroke Volume Variation (SVV),
* Heart Rate (HR),
* Ventricular Ejection Time (VET),
* Total Peripheral Resistance (TPR),
* Total Peripheral Resistance Index (TPRI),
* Cardiac Power (Cr),
*Cardiac Power Index (CP1),
* Oxygen Delivery Index (D021),
* Electrical impedance of the chest cavity (ZO),
*Thoracic Fluid Content (TEC)
* Thoracic Fluid Content change from preset time period (TFCdO and
* Thoracic Fluid Content from baseline (TFCdO).
* Orthostatic Bioreactance (Postural changes in SV, CO and other hemodynaniic parameters which are derived by Bioreactance)
The Cheetah Reliant with NIEP and SpO2 functionalities 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/K103166 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103166: Cheetah Reliant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103166
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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