510(k) · Cleared
ClearedNicas 2001 Noninvasive Cardio-Respiratory System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.L. Mcintosh & Assoc., Inc. · DSB Plethysmograph, Impedance
Cleared on Jun 28, 1996 after a 784-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 28, 1996
- Review
- 784 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK942227 Nicas 2001 Noninvasive Cardio-Respiratory SystemC.L. Mcintosh & Assoc., Inc. · 1996
- Descendant · cites it directly · 1 of its ownK070500 Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 SlimNi Medical · 2007
- Descendant · 2 generations on · 0 of its ownK080941 Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK972001 Nicas (TM) ElectrodeNi Medical · 1997
Most influential descendants
Showing 3 of 3 · See all- K070500Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 SlimNi Medical · 2007 · cites it directly1descendant
- K080941Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd. · 2009 · 2 generations on0descendants
- K972001Nicas (TM) ElectrodeNi Medical · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942227 | Nicas 2001 Noninvasive Cardio-Respiratory System | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| +1 | K070500 | Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim | Ni Medical | 2007 | — |
| +2 | K080941 | Bioimpedance Cardiac Analyzing Measuring System | N.I. Medical, Ltd. | 2009 | — |
| +1 | K972001 | Nicas (TM) Electrode | Ni Medical | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | — | BoMed NCCOM3-R7 Monitor Named without a submission number |
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070500 (Ni Medical, 2007) has gone furthest, with 1 descendant 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.
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 2001 is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance) and ventilatory parameters (respiratory rate) in males and females needing cardiac output assessment, including patients with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K942227 · printed Nov 4, 2026
Cite this page
510(k) Report. “K942227: Nicas 2001 Noninvasive Cardio-Respiratory System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K942227
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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