SOZO

K172122

ImpediMed Limited · cleared 2017-08-11 · product code OBH · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“The SOZO system consists of a connected hand and footplate with built-in stainless steel electrodes, paired with an Android tablet over Bluetooth connection. An app (“SOZOapp"), supplied with the tablet, controls the functionality of the hardware and supplies the bioimpedance measurement data to a database ("SOZOhub”) contained within the hospital/facility network. ... Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right limbs, and present the impedance ratio as an L-Dex® score for the clinician to review.”
AlgorithmEstablished algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right limbs, and present the impedance ratio as an L-Dex® score for the clinician to review. 'Sense' channels measure current (I), voltage (V) and phase angle (Ph), and calculates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc) to estimate extracellular fluid ratios, and calculate the impedance ratios which are converted to a L-Dex ratio.
source quote (p.2)
“'Sense' channels measure current (I), voltage (V) and phase angle (Ph), and calculates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc) to estimate extracellular fluid ratios, and calculate the impedance ratios which are converted to a L-Dex ratio;”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: correlation in L-Dex readings

standards: IEC 60601-1:2005/A1:2012 General Electrical and Mechanical Safety, IEC 60601-1-2:2014 Ed4.0 Electromagnetic Compatibility, IEC 60601-1-6:2010/A1:2013 Usability, EN/ISO 62304:2006 Medical device software - Software life-cycle processes, IEC 62366:2007/A1:2014 Application of usability engineering to medical devices, ISO 10993-1:2009/TC1:2010 Biological Evaluation of Medical Devices, ISO 10993-5:2009, Cytotoxicity, ISO 10993-10:2010, Test for Irritation and Skin Sensitization

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K190529 (decision 2019-11-25) from ImpediMed Limited for a matching device line ("SOZO") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K190529

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K180126 (decision 2018-04-16) from ImpediMed Limited for a matching device line ("SOZO") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K180126

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K172507 (decision 2017-12-22) from ImpediMed Limited for a matching device line ("SOZO") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K172507

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K172122