510(k) · Cleared
ClearedBio Z Cardio Profile Hemodynamic Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · DSB Plethysmograph, Impedance
Cleared on Jun 3, 2011 as substantially equivalent to K090602 (Cardiodynamics International Corp., 2009) and 3 other predicates after a 91-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Jun 3, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K903134 (1991). 61 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 7 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 6 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 5 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 4 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 3 generations backK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
- 2 generations backK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
- 1 generation backK103166 Cheetah ReliantCheetah Medical, Inc. · 2011
- This deviceK110645 Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −7 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −6 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −5 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −4 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −3 | K081590 | YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −2 | K083093 | Cheetah Reliant | Cheetah Medical, Inc. | 2008 | 1 |
| −1 | K103166 | Cheetah Reliant | Cheetah Medical, Inc. | 2011 | — |
| 0 (this device) | 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 |
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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? (4)
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 |
|---|---|---|---|
| * | K090602 | Cardiodynamics Bioz RX, Model 7101-SysSummary page 1…d within this submission is substantially equivalent to a combination of the Cardioflynamics BioZ Rx Hemodynamic Monitor and BioZ Dx Hemodynamic Monitor (K090602, K041 294), SphygmoCor CardioVascular Management System (K080670) and the Cheetah Reliant (K1 03166). 5.4. D… | 2009 |
| * | K041294 | Biozdx Hemodynamic MonitorSummary page 1…this submission is substantially equivalent to a combination of the Cardioflynamics BioZ Rx Hemodynamic Monitor and BioZ Dx Hemodynamic Monitor (K090602, K041 294), SphygmoCor CardioVascular Management System (K080670) and the Cheetah Reliant (K1 03166). 5.4. Device Desc… | 2004 |
| * | K080670 | Modification to Sphygmocor Cardiovascular Management SystemSummary page 1…tion of the Cardioflynamics BioZ Rx Hemodynamic Monitor and BioZ Dx Hemodynamic Monitor (K090602, K041 294), SphygmoCor CardioVascular Management System (K080670) and the Cheetah Reliant (K1 03166). 5.4. Device Description: The Bio Z Cardio Profile Hemodynamic Monitor… | 2008 |
| * | K103166 | Cheetah ReliantSummary page 1…Hemodynamic Monitor and BioZ Dx Hemodynamic Monitor (K090602, K041 294), SphygmoCor CardioVascular Management System (K080670) and the Cheetah Reliant (K1 03166). 5.4. Device Description: The Bio Z Cardio Profile Hemodynamic Monitor is a data acquisition system that… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 61 ancestors have a recall of any class.
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?
For the LOG function: The Bio Z Cardia Profile Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters including; Heart Rate (HR) Velocity Index (VI) Systolic Blood Pressure (SBP) Acceleration Index (ACl) Diastolic Blood Pressure (DBP) Heather Index (HI) Mean Arterial Pressure (MAP) Pre-Ejection Period (PEP) Pulse Wave Velocity (PWV) Left Ventricular Ejection lime (LVET) Oxygen Delivery Index (D001 Thoracic Fluid Content…
Read the full statement (141 words)
For the LOG function:
The Bio Z Cardia Profile Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters including;
Heart Rate (HR) Velocity Index (VI)
Systolic Blood Pressure (SBP) Acceleration Index (ACl)
Diastolic Blood Pressure (DBP) Heather Index (HI)
Mean Arterial Pressure (MAP) Pre-Ejection Period (PEP)
Pulse Wave Velocity (PWV) Left Ventricular Ejection lime (LVET)
Oxygen Delivery Index (D001 Thoracic Fluid Content (IFO)
Stroke Volume (SV) Thoracic Fluid Content Index (TFCI)
Stroke Index (SI) Baseline Impedance (ZO)
Cardiac Output (00) Total Arterial Compliance (TAO)
Cardiac Index (Cl) Total Arterial Compliance Index
(TAO 1)
Systemic Vascular Resistance (SVR) Systolic Time Ratio (STR)
Systemic Vascular Resistance Index Systolic Time Ratio Index (STRI)
(SVRI)
Left Cardiac Work (LCW)
Left Cardiac Work Index (LOWI)
The Bio Z Cardio Profile Hemodynamic Monitor is not intended to be used as a vital sign monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110645: Bio Z Cardio Profile Hemodynamic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110645
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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