510(k) · Cleared
ClearedIN-Check Inspiratory Flowmeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clement Clarke Intl., Ltd. · BZH Meter, Peak Flow, Spirometry
Cleared on Jun 10, 1998 after an 86-day review. The FDA summary names no predicate by number.
- Decided
- Jun 10, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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 IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient. Some uses for the device are :- 1. Diagnosis of Nasal Obstruction In some patients who complain of nasal obstruction, nasal airway patency is quite normal, and the symptom is due to consciousness of some other abnormality of the nasal…
Read the full statement (387 words)
The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient.
Some uses for the device are :-
1. Diagnosis of Nasal Obstruction
In some patients who complain of nasal obstruction, nasal airway patency is quite normal, and the symptom is due to consciousness of some other abnormality of the nasal cavity such as a prominent turbinate. In some cases, surprisingly low readings are obtained in some patients who are unaware of nasal obstruction, because they have got used to it. Quiet breathing through the nose can in such cases be achieved in spite of a peak nasal inspiratory flow readings as low as 50.
Such patients are often unaware that they breath through the mouth for much of the time.
Reversibility of nasal obstruction can be assessed by measuring PNIF after application of a nasal decongestant such as ephedrine by spray or drops. If the PNIF is not raised to a reading of over 100 by such treatment, then the obstruction may be associated with mucosal oedema, extensive polyps or anatomical abnormality. A trial of topical or systemic steroids may also bring the PNIF into the normal range (100 to 300 L/min.).
2. Assessment of Response to Nasal Provocation
Allergen or pharmocological mediator (e.g. histamine) application to the nasal mucosa in doses halving PNIF is usually associated with only minor and transient discomfort. Details of a simplified allergen provocation test using PNIF measurement have been published.
3. Home Monitoring of PNIF
This may be useful in drug or immunotherapy trials in rhinitis, or for assessing the importance of environmental factors at home or work in individual patients with rhinitis. Cyclic changes in nasal airway patency can also be investigated, as can late responses to allergen provocation.
4. Oral Inspiratory Flow Measurement
Measurements of sub-maximal inspiratory flows are valuable when training patients in the correct use of medical inhaler devices. Recent studies have indicated target inspiratory flows for many of the inhaled medication devices commonly used to deliver medication in respiratory diseases.
Feedback to the patient from IN-CHECK measurement enables the patient to adjust their inhalation technique to best suit their own inhaler.
Note: PNIF = Peak Nasal Inspiratory Flow
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/K980960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980960: IN-Check Inspiratory Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980960
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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