510(k) · Cleared
ClearedCardiac Monitor 1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zynex Medical, Inc. · DSB Plethysmograph, Impedance
Cleared on Feb 21, 2020 as substantially equivalent to K974725 (Cardiodynamics International Corp., 1998) and 2 other predicates after a 241-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Feb 21, 2020
- Review
- 241 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K972320 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 1 generation backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- This deviceK191697 Cardiac Monitor 1500Zynex Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK223217 Zynex Monitoring System, Model CM-1600Zynex Medical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −1 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| 0 (this device) | K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020 | — |
| +1 | K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K974725 | Bioz.Com SystemSummary page 5…Device Name Manufacturer 510(k) BioZ.com System CardioDynamics International Corporation K974725 Wrist Ox2 3150 Nonin Medical, Inc. K102350 TemporalScanner Thermometer Exerge… | 1998 |
| * | K102350 | Pulse OximeterSummary page 5…(k) BioZ.com System CardioDynamics International Corporation K974725 Wrist Ox2 3150 Nonin Medical, Inc. K102350 TemporalScanner Thermometer Exergen Corp. K011291 4. Description Cardiac Monitor, Model… | 2010 |
| * | K011291 | Temporalscanner Thermometer, SensortouchSummary page 5…725 Wrist Ox2 3150 Nonin Medical, Inc. K102350 TemporalScanner Thermometer Exergen Corp. K011291 4. Description Cardiac Monitor, Model 1500 and accessories monitor a patient’s parameters. These parameters include: Bioelec… | 2001 |
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 |
|---|---|---|---|
| K223217 | Zynex Monitoring System, Model CM-1600 | 2023 | 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 23 years and passes through 2 companies; a new generation was cleared every 21.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K223217 (Zynex Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K974725.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Monitoring of the following parameters and their relative changes, indicative of relative changes in fluid volume in adult patients.
• Bioelectrical Impedance
• Heart Rate
• ECG Amplitude
• PPG Amplitude
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191697: Cardiac Monitor 1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191697
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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