510(k) · Cleared
ClearedAsthma Monitor AM3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion Germany 234 GmbH · BZG Spirometer, Diagnostic
Cleared on Jan 13, 2010 as substantially equivalent to K090486 (Cardinal Health Germany 234 GmbH, 2009) after a 114-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Jan 13, 2010
- Review
- 114 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K980876 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK980876 Asthma Monitor AM2Erich Jaeger GmbH & Co. KG · 1998
- 1 generation backK090486 Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH · 2009
- This deviceK092890 Asthma Monitor AM3Carefusion Germany 234 GmbH · 2010
- Descendant · cites it directly · 2 of its ownK133722 Asthma Monitor AM3Eresearch Technology · 2014
- Descendant · 2 generations on · 0 of its ownK183479 Asthma Monitor AM3Eresearch Technology · 2019
- Descendant · 2 generations on · 0 of its ownK183586 CapMedicCognita Labs, LLC · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980876 | Asthma Monitor AM2 | Erich Jaeger GmbH & Co. KG | 1998 | — |
| −1 | K090486 | Asthma Monitor Model, AM1 | Cardinal Health Germany 234 GmbH | 2009 | — |
| 0 (this device) | K092890 | Asthma Monitor AM3 | Carefusion Germany 234 GmbH | 2010 | — |
| +1 | K133722 | Asthma Monitor AM3 | Eresearch Technology | 2014 | — |
| +2 | K183479 | Asthma Monitor AM3 | Eresearch Technology | 2019 | — |
| +2 | K183586 | CapMedic | Cognita Labs, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 2 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K980676 | FDA’s K980676 is Spigal Needle 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…g "The New 510(k) Paradigm" - Additional data transfer to computer by blue tooth - 5.9 Legally predicate marketed device Asthma Monitor AM3 K980676/A2 Code BZG Asthma Monitor AM1+ I AM1+ BT K090486 Code BZG 5.10 Pmedicate Device Company CareFusio… | 1998 |
| * | K090486 | Asthma Monitor Model, AM1Summary page 2…omputer by blue tooth - 5.9 Legally predicate marketed device Asthma Monitor AM3 K980676/A2 Code BZG Asthma Monitor AM1+ I AM1+ BT K090486 Code BZG 5.10 Pmedicate Device Company CareFusion Germany 234 GmbH (formerly: Cardinal Health Germany 234 GmbH) 5.1… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133722 | Asthma Monitor AM3 | 2014 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133722 (Eresearch Technology, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K090486.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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…
Read the full statement (292 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092890 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092890: Asthma Monitor AM3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092890
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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