Chrysalis Intelligence · Sponsors · Sonarmed, Inc.

Sonarmed, Inc.

Carmel, IN, US · 1 510(k) clearances · 4 recalls (4 Class I)

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Total clearances

1

2020-05-15 → 2020-05-15

Last 12 months

0

Product codes

1

Most recent

2020-05-15

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
OQU	Airway Monitoring System	Class II	Anesthesiology	1	2020-05-15

Safety

Recalls (4)

Class I (serious)

4

Risk of injury / death

Total recalls

4

Currently ongoing

4

Most recent

2024-03-25

Date	Severity	Status	Recall #	Product	Code	Reason
2024-03-25	Class I	Ongoing	Z-1535-2024	AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.	—	Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
2024-03-21	Class I	Ongoing	Z-1521-2024	AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.	—	The failure to detect the partial obstruction in a 2.5mm sensor.
2024-03-21	Class I	Ongoing	Z-1520-2024	AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.	—	The failure to detect the partial obstruction in a 2.5mm sensor.
2024-03-21	Class I	Ongoing	Z-1519-2024	AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.	—	The failure to detect the partial obstruction in a 2.5mm sensor.

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2020-05-15	K193058	SonarMed AirWave Airway Monitoring System	OQU	Class II	Anesthesiology