510(k) · Cleared
ClearedPeak Flow Meter (PF-10(BR-PEF231))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Bi-Rich Medical Devices Co., Ltd. · BZH Meter, Peak Flow, Spirometry
Cleared on May 29, 2026 as substantially equivalent to K140054 (Resmed, Ltd., 2014) after a 268-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- May 29, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K971260 (1997). 14 ancestors in all, the oldest K930656 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 7 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 6 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 5 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 4 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK050775 ResscanResmed, Ltd. · 2005
- 2 generations backK113815 ResscanResmed, Ltd. · 2012
- 1 generation backK140054 RescanResmed, Ltd. · 2014
- This deviceK252802 Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −7 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −6 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −5 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −4 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −2 | K113815 | Resscan | Resmed, Ltd. | 2012 | — |
| −1 | K140054 | Rescan | Resmed, Ltd. | 2014 | — |
| 0 (this device) | K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 K253180 Microlife Digital Peak Flow Meter, Model…score 12.5 · 4 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 |
|---|---|---|---|
| * | K140054 | RescanSummary page 6…ResScan Essentials Traditional 510(k) Legally Marketed ResScan (K140054) Predicate Device: Device ResScan Essentials is an offline desktop application specifically developed to function a… | 2014 |
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 3 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 5 other devices also cite its predicate K140054.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
ResScan Essentials is intended to augment the standard follow-up care of patients by transferring and analyzing machine and therapeutic information from ResMed compatible therapy devices to the ResScan Essentials application. ResScan Essentials is intended to be used by clinicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252802: Peak Flow Meter (PF-10(BR-PEF231)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252802
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026