510(k) · Cleared
ClearedAluna 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Knox Medical Diagnostics · BZH Meter, Peak Flow, Spirometry
Cleared on Nov 25, 2024 as substantially equivalent to K193311 (Knox Medical Diagnostics, Inc., 2020) after a 458-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Nov 25, 2024
- Review
- 458 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943678 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK943678 Electronic Flow MeterVitalograph, Inc. · 1995
- 5 generations backK982995 Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998
- 4 generations backK031024 Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003
- 3 generations backK040723 Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models…Microlife Intellectual Property GmbH · 2004
- 2 generations backK152276 Wing Smart FEVI and Peak Flow MeterSparo, Inc. · 2016
- 1 generation backK193311 AlunaKnox Medical Diagnostics, Inc. · 2020
- This deviceK232588 Aluna 2Knox Medical Diagnostics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943678 | Electronic Flow Meter | Vitalograph, Inc. | 1995 | — |
| −5 | K982995 | Accutrax, Model EPF840 | Korr Medical Technologies, Inc. | 1998 | — |
| −4 | K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100 | Microlife Corp. | 2003 | — |
| −3 | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and… | Microlife Intellectual Property GmbH | 2004 | — |
| −2 | K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016 | — |
| −1 | K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020 | — |
| 0 (this device) | K232588 | Aluna 2 | Knox Medical Diagnostics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 BZH? 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 BZH device
- #1 K252802 Peak Flow Meter (PF-10(BR-PEF231))score 13.5 · 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 |
|---|---|---|---|
| * | K193311 | AlunaSummary page 5…er Predicate Device Name / Manufacturer Primary Predicate K193311 Aluna manufactured by Knox Medical Diagnostics DEVICE DESCRIPTION Aluna 2 consists of three main… | 2020 |
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 29 years and passes through 7 companies; a new generation was cleared every 4.7 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · BZH
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZH
371in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZH
No recall names BZH since 2007.
Adverse event reports per year · BZH
1in 2015
MAUDE reports naming product code BZH, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 115 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 371 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232588: Aluna 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232588
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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