# K982487: CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics MO

- Pathway: 510(k) (Traditional)
- Applicant: Cardiopulmonary Technologies, Inc.
- Decided: Oct 14, 1998 after 89 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093080: Metaphor Metabolic Monitor (2010), 0 descendants of its own

## Indications for use
Meteor is a handheld respiratory mechanics graphic monitor intended for use in the hospital clinical environment and transport, either land or air. It is intended for monitoring mechanically ventilated or supported pediatric and adult patients with tidal volumes greater than 100 ml. Meteor can be used for either continuous (Meteor 200) or spot check usage (Meteor 100 and 200). It is not intended to be used as an apnea monitor. No alarms are provided. Warning: Federal law restricts the use or sale of this device by or on the order of a physician. Warning: Do not use this device in the presence of flammable anesthetics. Warning: Do not use this device in the presence of magnetic resonance imaging, MRI, equipment. Warning: In accessing patient conditions, Meteor is intended only as an adjunct measurement. Warning: Use of Meteor 100/ 200 in the presence of high concentrations of oxygen, helium-oxygen mixtures and anestetic agents may cause errors in the reported flow measurements.

Source page: https://510kreport.com/device/K982487
Methodology: https://510kreport.com/methodology