510(k) · Cleared
ClearedPeaklog and Display Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrac Technologies Corp. · BZH Meter, Peak Flow, Spirometry
Cleared on Nov 1, 1994 after a 251-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 30 later devices descend from it.
- Decided
- Nov 1, 1994
- Review
- 251 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK940835 Peaklog and Display SoftwareMedtrac Technologies Corp. · 1994
- Descendant · cites it directly · 27 of its ownK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
- Descendant · 2 generations on · 25 of its ownK091803 Smarttrack SystemNexus6, Ltd. · 2009
- Descendant · 3 generations on · 13 of its ownK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
- Descendant · 4 generations on · 12 of its ownK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
- Descendant · 3 generations on · 10 of its ownK133951 SmarttouchNexus6, Ltd. · 2014
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K970344Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997 · cites it directly27descendants
- K091803Smarttrack SystemNexus6, Ltd. · 2009 · 2 generations on25descendants
- K121609Asthmapolis SystemReciprocal Labs Corporation · 2012 · 3 generations on13descendants
- K140638Propeller System - Model 2Reciprocal Labs Corporation · 2014 · 4 generations on12descendants
- K133951SmarttouchNexus6, Ltd. · 2014 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940835 | Peaklog and Display Software | Medtrac Technologies Corp. | 1994 | — |
| +1 | K970344 | Mdilog, Model MDC-511 | Medtrak Technologies, Inc. | 1997 | — |
| +2 | K091803 | Smarttrack System | Nexus6, Ltd. | 2009 | — |
| +3 | K121609 | Asthmapolis System | Reciprocal Labs Corporation | 2012 | — |
| +4 | K140638 | Propeller System - Model 2 | Reciprocal Labs Corporation | 2014 | — |
| +3 | K133951 | Smarttouch | Nexus6, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K970344 (Medtrak Technologies, Inc., 1997) has gone furthest, with 27 descendants of its own.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K940835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940835: Peaklog and Display Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940835
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026