510(k) · Cleared
ClearedAluna
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Knox Medical Diagnostics, Inc. · BZH Meter, Peak Flow, Spirometry
Cleared on Mar 25, 2020 as substantially equivalent to K181666 (Mir Medical International Research, 2018) and 1 other predicate after a 117-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Mar 25, 2020
- Review
- 117 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943678 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK943678 Electronic Flow MeterVitalograph, Inc. · 1995
- 4 generations backK982995 Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998
- 3 generations backK031024 Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003
- 2 generations backK040723 Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models…Microlife Intellectual Property GmbH · 2004
- 1 generation backK152276 Wing Smart FEVI and Peak Flow MeterSparo, Inc. · 2016
- This deviceK193311 AlunaKnox Medical Diagnostics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK232588 Aluna 2Knox Medical Diagnostics · 2024
Most influential descendants
Showing 1 of 1 · See all- K232588Aluna 2Knox Medical Diagnostics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943678 | Electronic Flow Meter | Vitalograph, Inc. | 1995 | — |
| −4 | K982995 | Accutrax, Model EPF840 | Korr Medical Technologies, Inc. | 1998 | — |
| −3 | K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100 | Microlife Corp. | 2003 | — |
| −2 | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and… | Microlife Intellectual Property GmbH | 2004 | — |
| −1 | K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016 | — |
| 0 (this device) | K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020 | — |
| +1 | K232588 | Aluna 2 | Knox Medical Diagnostics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181666 | Smart OneSummary page 4…una is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K181666 Smart One / MIR Medical International Research K152276 Wing Smart FEV1 and Peak… | 2018 |
| * | K152276 | Wing Smart FEVI and Peak Flow MeterSummary page 4…cate Device Name / Manufacturer Primary Predicate K181666 Smart One / MIR Medical International Research K152276 Wing Smart FEV1 and Peak Flow Meter / Sparo Inc. DEVICE DESCRIPTION Aluna is a small hand-held peak flow… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232588 | Aluna 2 | 2024 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K232588 (Knox Medical Diagnostics, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181666.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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 children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.
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/K193311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193311: Aluna.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193311
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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