Chrysalis Intelligence · Sponsors · ImpediMed Limited

ImpediMed Limited

Pinkenba, AU · 7 510(k) clearances · 1 recalls

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Total clearances

7

2020-10-02 → 2026-08-17

Last 12 months

2

Product codes

3

Most recent

2026-08-17

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
DSB	Plethysmograph, Impedance	Class II	Cardiovascular	4	2026-08-17
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Class II	Cardiovascular	2	2026-01-28
QJB	Adjunct Monitor, Protein Calorie Malnutrition	Class II	Cardiovascular	1	2023-05-04

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2023-08-17

Date	Severity	Status	Recall #	Product	Code	Reason
2023-08-17	Class II	Ongoing	Z-0155-2024	SOZO Bilateral Arm L-Dex Software	—	Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment,…

Filings

All 510(k) clearances (7)

Date	K-number	Device	Code	Class	Specialty
2026-08-17	K260224	MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)	DSB	Class II	Cardiovascular
2026-01-28	K253224	MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)	OBH	Class II	Cardiovascular
2023-10-17	K232089	SOZO Pro	DSB	Class II	Cardiovascular
2023-05-04	K230531	SOZO Pro	QJB	Class II	Cardiovascular
2023-05-04	K230530	SOZO Pro	OBH	Class II	Cardiovascular
2021-04-19	K203473	SOZO	DSB	Class II	Cardiovascular
2020-10-02	K193410	SOZO Body Fluid Analyzer	DSB	Class II	Cardiovascular