# K183479: Asthma Monitor AM3

- Pathway: 510(k) (Special)
- Applicant: Eresearch Technology
- Decided: Oct 3, 2019 after 290 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980876 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133722: Asthma Monitor AM3, Eresearch Technology (2014) Summary page 5.

## Indications for use
The Asthma Monitor AM3 G+ is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM3 is used to monitor the respiratory status of human beings (adults and children 5 years and older) in the areas of asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for the selected parameters (e.g. PEF, FEV1). Furthermore, a visual control unit, displayed in the form of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient’s physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. In addition, (symptom and medications) questionnaire functionality can be called up by the use of a software (AMOS) to record e.g. the “Quality of Life”status. When enabled, the AM3 can be programmed with a couple of questions, where the patient can then select from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation using the software AMOS. The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. The asthma monitor AM3 is intended to be used in health care, clinical and home use environments.

Source page: https://510kreport.com/device/K183479
Methodology: https://510kreport.com/methodology