510(k) Report

510(k) · Cleared

Cleared

Bioz System

K963183510(k) TraditionalCleared Nov 26, 1996104-day reviewClass II21 CFR 870.2770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiodynamics International Corp. · DSB Plethysmograph, Impedance

Cleared on Nov 26, 1996 after a 104-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 14 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.

Decided
Nov 26, 1996
Review
104 days
Class
Class II
Product code
DSB
Recalls
None
Predicates
0

13 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2003: 2 descendants cleared2010: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963183 Bioz SystemCardiodynamics International Corp. · 1996
  2. Descendant · cites it directly · 12 of its ownK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
  3. Descendant · 2 generations on · 11 of its ownK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
  4. Descendant · 3 generations on · 8 of its ownK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
  5. Descendant · 4 generations on · 4 of its ownK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
  6. Descendant · 5 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2003: 22010: 12011: 12012: 12013: 22014: 12017: 12022: 12023: 12025: 12026: 1
2003high 2 (2003) · low 0 (2004)2026

Class I recalls in this family

  • K112686 Next Gen Emg Endotracheal Tube4 generations on · 2012

Most influential descendants

Showing 5 of 13 · See all
  • K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003 · cites it directly12descendants
  • K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003 · 2 generations on11descendants
  • K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010 · 3 generations on8descendants
  • K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · 4 generations on4descendants
  • K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963183Bioz SystemCardiodynamics International Corp.1996—
+1K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical2003—
+2K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc.2003—
+3K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc.2010—
+4K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.201110
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
201010
201110
201211
201320
201410
201710
202210
202310
202510
202610
FIG. 1 — Lineage of K963183, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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. #1 K232089 SOZO Proscore 14.6 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical200312

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K021174 (Imagyn Surgical, 2003) has gone furthest, with 12 descendants of its own.

How does its category compare?

All DSB devices

DSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSB

3in 2025

2007: 22008: 62009: 22010: 12011: 22012: 12013: 22014: 22015: 22017: 22018: 12019: 12020: 22021: 12022: 12023: 22025: 32026 (partial year): 1
2007high 6 (2008) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSB

266in 2025

2008: 90 days median2025: 266 days median
2007high 266 (2025) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSB

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSB

2in 2025

2016: 12025: 2
2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code DSB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200869000
20092—00
20101—00
20112—00
20121—00
20132—00
20142—00
20152—10
20160—01
20172—00
20181—00
20191—00
20202—00
20211—00
20221—00
20232—00
20240—00
2025326602
20261—0—

More from Cardiodynamics International Corp.

11 FDA decisions under this applicant name. See the company

  • K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
  • K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
  • K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
  • K041294Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 2004
  • K011439Modification to Bioz.Com Hemodynamic MonitorCardiodynamics International Corp. · 2001

Recent decisions in DSB

The DSB category page

  • K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited · 2026
  • K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC · 2025
  • K243727Re:BalansMode Sensors AS · 2025
  • K250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical, Ltd. · 2025
  • K232089SOZO ProImpediMed Limited · 2023

https://510kreport.com/device/K963183 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963183: Bioz System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963183

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026