# K092890: Asthma Monitor AM3

- Pathway: 510(k) (Special)
- Applicant: Carefusion Germany 234 GmbH
- Decided: Jan 13, 2010 after 114 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: 2 generations back to K980876 (1998). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090486: Asthma Monitor Model, AM1, Cardinal Health Germany 234 GmbH (2009) Summary page 2.

## Cited in the summary but kept off the family tree
- K980676: Spigal Needle, Gallini U.S., LLC (1998). Our reading of the summary gave K980676, FDA’s number for Spigal Needle (Gallini U.S., LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Asthma Monitor AM3”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K133722: Asthma Monitor AM3 (2014), 2 descendants of its own
- K183479: Asthma Monitor AM3 (2019), 0 descendants of its own
- K183586: CapMedic (2019), 0 descendants of its own

## Indications for use
The Asthma Monitor AM3 I AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flaws and volume) with high reproducibility wherever and whenever is a need of. The AM3 / AM3 BT measures the flaw during expiration serving for the calculation of further parameters as FEVI1. The AM3 I AM3 BT Is used to monitor the respiratory status of human beings in the areas 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 selected parameters (e.g., PEF, FEVI). Furthermore a visual control unit, displayed as a kind 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. The memory capacity Is designed to store up to 800 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the *Quality of Life status. When enabled, the AM3 I AM3 BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted far evaluation to a standard PC using the software package AMOS. The AM3 I AM3 BT Is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

Source page: https://510kreport.com/device/K092890
Methodology: https://510kreport.com/methodology