510(k) · Cleared
ClearedRespalert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harwill Medical (Pty), Ltd. · BZH Meter, Peak Flow, Spirometry
Cleared on Oct 29, 1999 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 29, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 | — |
What is it indicated for?
The Harwill Medical RESPALERT is a peak flow monitor that kas been-desigred to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control. The…
Read the full statement (146 words)
The Harwill Medical RESPALERT is a peak flow monitor that kas been-desigred to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992618: Respalert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992618
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026