510(k) · Cleared
ClearedAsthma Monitor AM2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erich Jaeger GmbH & Co. KG · BZG Spirometer, Diagnostic
Cleared on Aug 14, 1998 after a 161-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Aug 14, 1998
- Review
- 161 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK980876 Asthma Monitor AM2Erich Jaeger GmbH & Co. KG · 1998
- Descendant · cites it directly · 14 of its ownK090486 Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH · 2009
- Descendant · 2 generations on · 9 of its ownK092324 SpiroproViasys Healthcare GmbH · 2009
- Descendant · 3 generations on · 6 of its ownK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- Descendant · 2 generations on · 3 of its ownK092890 Asthma Monitor AM3Carefusion Germany 234 GmbH · 2010
- Descendant · 4 generations on · 2 of its ownK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K090486Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH · 2009 · cites it directly14descendants
- K092324SpiroproViasys Healthcare GmbH · 2009 · 2 generations on9descendants
- K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010 · 3 generations on6descendants
- K092890Asthma Monitor AM3Carefusion Germany 234 GmbH · 2010 · 2 generations on3descendants
- K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980876 | Asthma Monitor AM2 | Erich Jaeger GmbH & Co. KG | 1998 | — |
| +1 | K090486 | Asthma Monitor Model, AM1 | Cardinal Health Germany 234 GmbH | 2009 | — |
| +2 | K092324 | Spiropro | Viasys Healthcare GmbH | 2009 | — |
| +3 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| +2 | K092890 | Asthma Monitor AM3 | Carefusion Germany 234 GmbH | 2010 | — |
| +4 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090486 | Asthma Monitor Model, AM1 | 2009 | 14 |
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?
- Of its descendants, K090486 (Cardinal Health Germany 234 GmbH, 2009) has gone furthest, with 14 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.
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 AM2 from JAEGER 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 AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75. The AM2 is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary…
Read the full statement (278 words)
The Asthma Monitor AM2 from JAEGER 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 AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.
The AM2 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, FEV1).
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 AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM2 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 AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980876: Asthma Monitor AM2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980876
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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