# K980960: IN-Check Inspiratory Flowmeter

- Pathway: 510(k) (Traditional)
- Applicant: Clement Clarke Intl., Ltd.
- Decided: Jun 10, 1998 after 86 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
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

Source page: https://510kreport.com/device/K980960
Methodology: https://510kreport.com/methodology