SOZO

K180126

ImpediMed Limited · cleared 2018-04-16 · product code OBH · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“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.”
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.5)
“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. '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)No
PCCPNo
Cybersecurity addressedNo

Validation studies (6)

Bench

sample size not stated

standards: IEC 60601 (subparts -1, -1-2, and -1-6)

Bench

sample size not stated

standards: ISO 62304

Bench

sample size not stated

standards: ISO 10993

Bench

sample size not stated

Retrospective clinical

sample size not stated

endpoints: applicability of ImpediMed's BIS technology to act as an aid in the clinical assessment of bilateral lymphedema; demonstrating strong correlation of extracellular fluid levels between at-risk and ipsilateral limbs (e.g. left leg vs. left arm)

Bench

n=0 other

endpoints: verify correlation in outputs

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
1
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

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/K180126