510(k) · Cleared
ClearedPeak Expiratory Flow Meter, KN-9710
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K-Jump Health Co., Ltd. · BZH Meter, Peak Flow, Spirometry
Cleared on Apr 9, 2010 as substantially equivalent to K010009 (Pds Healthcare Products, Inc., 2001) and 1 other predicate after a 248-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Apr 9, 2010
- Review
- 248 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K943678 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK943678 Electronic Flow MeterVitalograph, Inc. · 1995
- 3 generations backK982995 Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998
- 2 generations backK031024 Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003
- 1 generation backK040723 Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models…Microlife Intellectual Property GmbH · 2004
- This deviceK092335 Peak Expiratory Flow Meter, KN-9710K-Jump Health Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943678 | Electronic Flow Meter | Vitalograph, Inc. | 1995 | — |
| −3 | K982995 | Accutrax, Model EPF840 | Korr Medical Technologies, Inc. | 1998 | — |
| −2 | K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100 | Microlife Corp. | 2003 | — |
| −1 | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and… | Microlife Intellectual Property GmbH | 2004 | — |
| 0 (this device) | K092335 | Peak Expiratory Flow Meter, KN-9710 | K-Jump Health Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K010009 | Koko Peak KP; Koko Peak KP+Summary page 1…K-jump Health Co., Ltd. Peak Flow Meter, Model KN-9710 3. Common or Usual Name: Peak Flow Meter [ 21 CFR 868.1860] 4. Predicate Device Information: - K010009, Peak Flow MeterModel KoKo Peak KP and KP+, POSHealth Products, Inc., U.S.A - K040723, Peak Flow Meter with PEF and… | 2001 |
| * | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1…Summary page 1…w Meter [ 21 CFR 868.1860] 4. Predicate Device Information: - K010009, Peak Flow MeterModel KoKo Peak KP and KP+, POSHealth Products, Inc., U.S.A - K040723, Peak Flow Meter with PEF and FEV1, Model PF-100, MicrolifelIntellectual Property GmbH, Switzerland… | 2004 |
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 15 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K010009.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
K-jumnp Health Go, Ltd. Peak Flow Meter, Model KN-9710, is intended for monitoring expiratory-breath function at home under direction of a physician or licensed health care professional. It measures the peak expiratory flow (PEF) and timed forced expiratory volumes over 1 second (FEVI). This device can be used from 6-year-old children to adult patients for monitoring and managing of chronic respiratory conditions, especially asthma and COPO.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092335: Peak Expiratory Flow Meter, KN-9710.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092335
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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