Cpt, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, Cpt, Inc. Meteor Hand Held Respiratory Mechanics Mo
by Cardiopulmonary Technologies, Inc.
510(k) K982487
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982487 | Date14 Oct 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BZC
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1880
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Meteor Hand-Held Respiratory Mechanics Monitor Meteor 100 is a handheld device designed for measuring and displaying respiratory mechanics data. It falls under the classification of a calculator for pulmonary function data, providing real-time assessment of ventilatory parameters in clinical settings.
This device is intended for use in hospital environments, including transport, for monitoring mechanically ventilated or supported pediatric and adult patients with tidal volumes greater than 100 ml. Supplied as a reusable Class II medical device under FDA 510(k) clearance (K982487), it operates without sterility requirements and adheres to regulatory standards for respiratory monitoring equipment. The device is not MRI-safe and must be stored according to manufacturer guidelines.
Questions
AI-generated answers, 19 Sep 2026
What types of patients is the Meteor 100 designed to monitor, and what are the key conditions for its use?
The Meteor 100 is designed for monitoring mechanically ventilated or supported pediatric and adult patients with tidal volumes greater than 100 ml. It is intended for use in hospital environments, including transport settings, to provide real-time assessment of ventilatory parameters. The device is specifically categorized under pulmonary function data calculators and is not intended for use with patients outside these parameters.
Is the Meteor 100 a single-use or reusable device, and what are the sterility requirements?
The Meteor 100 is a reusable Class II medical device. Unlike single-use devices, it does not require sterility for operation, but it must be handled and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene in clinical settings.
Can the Meteor 100 be used in an MRI environment, and how should it be stored?
No, the Meteor 100 is not MRI-safe, meaning it should not be used or stored in an MRI environment. Storage instructions are provided by the manufacturer, and adherence to these guidelines is essential to maintain device performance and safety.
What regulatory pathway was followed for the approval of the Meteor 100, and what medical specialty is it associated with?
The Meteor 100 was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type, with a decision code of SESE (Substantially Equivalent). It was reviewed by the Anesthesiology Advisory Committee (AN) and is associated with the medical specialty of anesthesiology, reflecting its role in respiratory monitoring for ventilated patients.
How does the Meteor 100 differ from other respiratory monitoring devices in terms of its intended use?
Unlike some respiratory monitoring devices that may focus on continuous long-term tracking, the Meteor 100 is a handheld calculator specifically designed for real-time assessment of ventilatory parameters in mechanically ventilated or supported patients. Its portability and handheld design make it particularly suited for use during patient transport within hospital settings, ensuring flexibility in clinical workflows.