510(k) · Cleared
ClearedZynex Monitoring System, Model CM-1600
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 Jun 16, 2023 as substantially equivalent to K191697 (Zynex Medical, Inc., 2020) after a 242-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jun 16, 2023
- Review
- 242 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972320 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 2 generations backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- 1 generation backK191697 Cardiac Monitor 1500Zynex Medical, Inc. · 2020
- This deviceK223217 Zynex Monitoring System, Model CM-1600Zynex Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −2 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| −1 | K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K191697 | Cardiac Monitor 1500Summary page 5…Name Manufacturer 510(k) Cardiac Monitor, Model 1500 (CM- Zynex Medical, Inc. K191697 1500) 4. Description Patient monitoring with the CM-1600 is intended to provide data to clinicians, doctors, and post- operati… | 2020 |
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 26 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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
• ECG Amplitude
• PPG Amplitude
• Skin Temperature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223217: Zynex Monitoring System, Model CM-1600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223217
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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