# K021389: Biological Sound Monitor (BSM) Sensor

- Pathway: 510(k) (Abbreviated)
- Applicant: Andromed, Inc.
- Decided: Oct 1, 2002 after 152 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
156 later devices descend from it; 1 cites it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter (2010), 115 descendants of its own
- K110028: Masimo Radical Y Pulse CO-Oximeter (2011), 89 descendants of its own
- K110516: Connex Vital Signs Monitor 6000 Series (2011), 67 descendants of its own
- K112687: Connex (R) Vital Signs Monitor 6000 Series (2011), 66 descendants of its own

## Indications for use
The Biological Sound Monitor Sensor is intended for the purpose of capturing, detecting and transmitting biological sounds such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The Biological Sound Monitor Sensor may be used with any compatible devices that may amplify biological sound signals for auscultation, display or further processing. The Biological Sound Monitor Sensor is indicated for use with children and adults under the supervision of a physician or other trained health care professional. It is indicated for use during routine exam in clinical or other suitably prescribed environment in conjunction with such devices as an electronic stethoscope. In no way are any of the sensor functions represented as being in and of themselves diagnostic. Sound signals must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

Source page: https://510kreport.com/device/K021389
Methodology: https://510kreport.com/methodology