# K090486: Asthma Monitor Model, AM1

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health Germany 234 GmbH
- Decided: May 6, 2009 after 70 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: 1 generation back to K980876 (1998). 1 ancestor in all.
14 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980876: Asthma Monitor AM2, Erich Jaeger GmbH & Co. KG (1998). Our reading of the summary gave K980676, FDA’s number for Spigal Needle (Gallini U.S., LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Asthma Monitor AM2”. Summary page 4.

## Most influential descendants
- K092324: Spiropro (2009), 9 descendants of its own
- K100687: Vitalograph Hand Held Spirometer, Model 2120 (2010), 6 descendants of its own
- K092890: Asthma Monitor AM3 (2010), 3 descendants of its own
- K200550: Vitalograph Model 2120 In2itive eDiary (2020), 2 descendants of its own
- K133722: Asthma Monitor AM3 (2014), 2 descendants of its own

## Indications for use
The Asthma Monitor AMI+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ /AM1+ BT measures the flow dudring expiration serving for the calculation of further parameters as FEV1. The AM1+ /AM1+ 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, FEVl). 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 400 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 AM1+ I AM1+ 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 for evaluation toa standard PC using the software package AMOS. The AM1 + / AM1 + BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ /AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.

Source page: https://510kreport.com/device/K090486
Methodology: https://510kreport.com/methodology