510(k) · Cleared
ClearedAsthma Monitor AM3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eresearch Technology · BZG Spirometer, Diagnostic
Cleared on Oct 3, 2019 as substantially equivalent to K133722 (Eresearch Technology, 2014) after a 290-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Oct 3, 2019
- Review
- 290 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K980876 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK980876 Asthma Monitor AM2Erich Jaeger GmbH & Co. KG · 1998
- 3 generations backK090486 Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH · 2009
- 2 generations backK092890 Asthma Monitor AM3Carefusion Germany 234 GmbH · 2010
- 1 generation backK133722 Asthma Monitor AM3Eresearch Technology · 2014
- This deviceK183479 Asthma Monitor AM3Eresearch Technology · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980876 | Asthma Monitor AM2 | Erich Jaeger GmbH & Co. KG | 1998 | — |
| −3 | K090486 | Asthma Monitor Model, AM1 | Cardinal Health Germany 234 GmbH | 2009 | — |
| −2 | K092890 | Asthma Monitor AM3 | Carefusion Germany 234 GmbH | 2010 | — |
| −1 | K133722 | Asthma Monitor AM3 | Eresearch Technology | 2014 | — |
| 0 (this device) | K183479 | Asthma Monitor AM3 | Eresearch Technology | 2019 | — |
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 |
|---|---|---|---|
| * | K133722 | Asthma Monitor AM3Summary page 5…ties via TCP/IP - Change in operating system of device accessory software AMOS 9 Legally predicate marketed device Asthma Monitor AM3 GSM K133722 Code BZG 10 Predicate Device Company eResearchTechnology GmbH 11 Device Description The Asthma Mon… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K133722.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 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…
Read the full statement (253 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183479 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183479: Asthma Monitor AM3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183479
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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