Cardiovascular · 510(k) · 2017
SOZO
ImpediMed Limited. Cleared by FDA on 22 December 2017 under submission K172507, product code DSB (plethysmograph, impedance). What FDA's record says, in FDA's words.
Device record · K172507
- Device. SOZODEVICE
- Company. ImpediMed Limited (AU)COMPANY
- Decision. 22 December 2017, 510(k), substantially equivalent (traditional review); received 18 August 2017DECISION
- Panel. CardiovascularPANEL
- Product code. DSB, Plethysmograph, ImpedanceCODE
- Regulation. 21 CFR 870.2770, Class IIREG
- Source. FDA database entry · decision document (6 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The SOZO Fluid Status Monitor is intended for adult patientsOLYLQJZLWKKHDUWIDLOXUH 7KLVGHYLFHLVLQWHQGHGIRUXVHXQGHUWKHGLUHFWLRQRIDSK\VLFLDQIRUWKHQRQLQYDVLYHPRQLWRULQJRISDWLHQWVZLWKIOXLG PDQDJHPHQWSUREOHPVVXIIHULQJIURPKHDUWIDLOXUH'DWDIURPWKHGHYLFHVKRXOGEHFRQVLGHUHGLQFRQMXQFWLRQZLWKRWKHU FOLQLFDOGDWD
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 8 reports filed against devices carrying product code DSB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
15 September 2026 · Malfunction · PRESSURE CONTROLLER KIT · Edwards Lifesciences Irvine · report 2015691-2026-18561
It was reported that during use of the Pressure Controller it gave inaccurate readings. There was no allegation of patient injury.
15 September 2026 · Malfunction · PRESSURE CONTROLLER KIT · Edwards Lifesciences IRV · report 2015691-2026-18562
It was reported that during use of the Pressure Controller it gave inaccurate readings. There was no allegation of patient injury.
28 January 2026 · Malfunction · EV1000 · EDWARDS LIFESCIENCES IRVINE · report 2015691-2026-10622
IT WAS REPORTED THAT DURING USE OF THE PRESSURE CONTROLLER IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 70 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 30 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON. IT WAS ON THE OPPOSITE ARM THEN IT WAS MOVED TO THE SAME SIDE AS THE ACUMEN CUFF. REPLACING THE […]
28 January 2026 · Malfunction · EV1000 · EDWARDS LIFESCIENCES IRVINE · report 2015691-2026-10625
IT WAS REPORTED THAT DURING USE OF THE PRESSURE CONTROLLER IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 70 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 30 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON. IT WAS ON THE OPPOSITE ARM THEN IT WAS MOVED TO THE SAME SIDE AS THE ACUMEN CUFF. REPLACING THE […]
24 June 2025 · Malfunction · EV1000 · EDWARDS LIFE SCIENCES · report 2015691-2025-05150
IT WAS REPORTED THAT, DURING USE, THE STAFF NOTICED A BLOOD PRESSURE (BP) DIFFERENCE BETWEEN THE CLEARSIGHT AND NON-INVASIVE BLOOD PRESSURE. THE CLEARSIGHT CONSISTENTLY SHOWED LOW MEAN ARTERIAL PRESSURE (MAP) VS. SIMULTANEOUS NON-INVASIVE BLOOD PRESSURE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DSB, in Cardiovascular, from ImpediMed Limited, or cleared in 2017. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.