Spirometer, Incentive Catalog #1750
by Hudson Oxygen Therapy Sales Co. 510(k)
Active
510(k) K781831
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781831 | Date15 Dec 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5690
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Spirometer, Incentive Catalog #1750 is a therapeutic incentive spirometer, a device designed to measure and display a patient’s breathing volume or flow. It encourages improved ventilation by providing visual feedback to motivate patients to achieve higher lung volumes, aiding in respiratory rehabilitation and postoperative recovery.
This device is intended for use in clinical settings, such as hospitals and outpatient care, and is classified as a Class II medical device under FDA regulations (product code BWF). Supplied as a reusable instrument, it requires proper cleaning and maintenance to ensure sterility and functionality. The device holds an FDA 510(k) clearance (K781831) and is regulated under the applicable special controls for spirometers, including performance standards for accuracy and safety.
Other devices from Hudson Oxygen Therapy Sales Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Hudson Incentive Spirometer #1750 used for?
The Hudson Incentive Spirometer #1750 is designed to help patients improve their lung ventilation by providing visual feedback on breathing volume. It encourages deeper breaths, which aids in respiratory rehabilitation and postoperative recovery by motivating patients to achieve higher lung volumes. This is particularly useful in clinical settings like hospitals and outpatient care.
Is the Hudson Incentive Spirometer #1750 single-use or reusable?
The Hudson Incentive Spirometer #1750 is supplied as a reusable instrument. To maintain its functionality and ensure sterility, it requires proper cleaning and maintenance between uses. This approach allows for repeated use in clinical environments while adhering to hygiene protocols.
How is the sterility of the Hudson Incentive Spirometer #1750 maintained?
Since the device is reusable, sterility is maintained through proper cleaning and maintenance procedures outlined by the manufacturer. Regular disinfection and adherence to clinical hygiene standards are essential to prevent contamination and ensure safe reuse across multiple patients. Always follow the manufacturer’s instructions for cleaning and sterilization.
What regulatory approval does the Hudson Incentive Spirometer #1750 hold?
The Hudson Incentive Spirometer #1750 holds an FDA 510(k) clearance (K781831), confirming it meets the agency’s performance standards for accuracy and safety. It is classified as a Class II medical device under FDA regulations, specifically under product code BWF, and is intended for use in clinical settings like hospitals and outpatient care.
Are there different models or sizes available for the Hudson Incentive Spirometer?
The provided data does not specify multiple models or sizes for the Hudson Incentive Spirometer #1750, but it is listed under multiple registration numbers, which may correspond to variations or lot-specific identifiers. For precise details on available models or sizes, refer to the manufacturer’s documentation or contact Hudson Oxygen Therapy Sales Co. directly.