LDW Spirometry System
by Lanpher Diagnostic Workstations, Inc.
510(k) K896300
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896300 | Date3 Apr 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The LDW Spirometry System is a diagnostic device classified as a spirometer, designed to measure lung function parameters such as forced expiratory volume (FEV₁), forced vital capacity (FVC), and peak expiratory flow. It evaluates respiratory health by assessing airflow obstruction, restriction, and overall pulmonary function, aiding in the diagnosis and monitoring of conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other cardiopulmonary disorders.
This system is intended for use in clinical settings, including hospitals, pulmonary function laboratories, and physician offices. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate readings. The LDW Spirometry System adheres to regulatory standards outlined in 21 CFR 868.1840 and holds an FDA 510(k) clearance (K896300) under the Traditional pathway, with a decision date of April 3, 1990. It is not classified as MRI-safe or MRI-conditional, and no specific sterility or single-use designation is noted in the regulatory data.
Questions
AI-generated answers, 20 Sep 2026
What clinical conditions is the LDW Spirometry System primarily used to diagnose or monitor?
The LDW Spirometry System is designed to evaluate respiratory health by measuring lung function parameters like forced expiratory volume (FEV₁), forced vital capacity (FVC), and peak expiratory flow. It aids in diagnosing and monitoring conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other cardiopulmonary disorders by assessing airflow obstruction, restriction, and overall pulmonary function.
Is the LDW Spirometry System intended for single-use or reusable applications, and what maintenance is required?
The LDW Spirometry System is supplied as a reusable medical device, meaning it is not intended for single-use. To ensure accurate readings, it requires proper calibration and maintenance as outlined in the manufacturer’s instructions and regulatory standards (21 CFR 868.1840).
Where can the LDW Spirometry System be used, and what types of clinical settings are appropriate?
The LDW Spirometry System is intended for use in clinical settings such as hospitals, pulmonary function laboratories, and physician offices. Its design and regulatory clearance support its deployment in environments where respiratory health assessments are conducted.
How was the LDW Spirometry System approved by the FDA, and what does the Traditional pathway clearance mean?
The LDW Spirometry System holds an FDA 510(k) clearance (K896300) under the Traditional pathway, granted on April 3, 1990. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the same regulatory requirements for safety and effectiveness as its predecessor.
Is the LDW Spirometry System compatible with MRI environments, and what safety considerations should be noted?
The LDW Spirometry System is explicitly not classified as MRI-safe or MRI-conditional. This means it should not be used in or near MRI environments, as there are no documented assurances regarding its safety or performance in such settings.