510(k) · Cleared
ClearedAsthma Monitor Model, AM1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health Germany 234 GmbH · BZG Spirometer, Diagnostic
Cleared on May 6, 2009 as substantially equivalent to K980876 (Erich Jaeger GmbH & Co. KG, 1998) after a 70-day review. Its family tree reaches back 1 generation to 1998. 14 later devices descend from it.
- Decided
- May 6, 2009
- Review
- 70 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980876 (1998). 14 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980876 Asthma Monitor AM2Erich Jaeger GmbH & Co. KG · 1998
- This deviceK090486 Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH · 2009
- Descendant · cites it directly · 9 of its ownK092324 SpiroproViasys Healthcare GmbH · 2009
- Descendant · 2 generations on · 6 of its ownK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK092890 Asthma Monitor AM3Carefusion Germany 234 GmbH · 2010
- Descendant · 3 generations on · 2 of its ownK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK133722 Asthma Monitor AM3Eresearch Technology · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K092324SpiroproViasys Healthcare GmbH · 2009 · cites it directly9descendants
- K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010 · 2 generations on6descendants
- K092890Asthma Monitor AM3Carefusion Germany 234 GmbH · 2010 · cites it directly3descendants
- K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020 · 3 generations on2descendants
- K133722Asthma Monitor AM3Eresearch Technology · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980876 | Asthma Monitor AM2 | Erich Jaeger GmbH & Co. KG | 1998 | — |
| 0 (this device) | K090486 | Asthma Monitor Model, AM1 | Cardinal Health Germany 234 GmbH | 2009 | — |
| +1 | K092324 | Spiropro | Viasys Healthcare GmbH | 2009 | — |
| +2 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| +1 | K092890 | Asthma Monitor AM3 | Carefusion Germany 234 GmbH | 2010 | — |
| +3 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| +2 | K133722 | Asthma Monitor AM3 | Eresearch Technology | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980876 | Asthma Monitor AM2 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”. | 1998 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K092324 (Viasys Healthcare GmbH, 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (311 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090486 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090486: Asthma Monitor Model, AM1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090486
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026