510(k) · Cleared
ClearedBioimpedance Cardiac Analyzing Measuring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N.I. Medical, Ltd. · DSB Plethysmograph, Impedance
Cleared on Jun 18, 2009 as substantially equivalent to K070500 (Ni Medical, 2007) and 1 other predicate after a 441-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Jun 18, 2009
- Review
- 441 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K895520 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 4 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
- 2 generations backK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
- 1 generation backK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
- This deviceK080941 Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −4 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −3 | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… | Philips Medical Systems | 2003 | — |
| −2 | K051228 | Biozdx Hemodynamic Monitor and 12-Lead Ecg | Cardiodynamics International Corp. | 2005 | — |
| −1 | K070156 | Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 | Cardiodynamics International Corp. | 2007 | — |
| 0 (this device) | K080941 | Bioimpedance Cardiac Analyzing Measuring System | N.I. Medical, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K070500 | Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 SlimSummary page 1…cation name: Impedance Plethysmograph Predicate Devices: NICaS 2004 Slim Noninvasive Cardio- Respiratory System (51 0(k) number K070500) and the, BIO Z HemoDynamic Monitor (51 0(k) number K0701 56) Device Desc… | 2007 |
| * | K070156 | Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Summary page 1…Respiratory System (51 0(k) number K070500) and the, BIO Z HemoDynamic Monitor (51 0(k) number K0701 56) Device Description: The NICaS (non-invasive cardiac system) CS is a CD-ROM shaped device which replaces the actual CD-Rom of a… | 2007 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 16 ancestors has 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. 2009, 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 NICaS CS is intended to monitor and display a patients hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, total peripheral resistance, and the Granov-Goor Index), in males and females with known or suspected cardiac disorders needing cardiac assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080941 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080941: Bioimpedance Cardiac Analyzing Measuring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080941
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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