510(k) · Cleared
ClearedCPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics MO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiopulmonary Technologies, Inc. · BZC Calculator, Pulmonary Function Data
Cleared on Oct 14, 1998 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 14, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK982487 CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100…Cardiopulmonary Technologies, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK093080 Metaphor Metabolic MonitorTreymed, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093080Metaphor Metabolic MonitorTreymed, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982487 | CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc.… | Cardiopulmonary Technologies, Inc. | 1998 | — |
| +1 | K093080 | Metaphor Metabolic Monitor | Treymed, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZC device
- #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093080 | Metaphor Metabolic Monitor | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093080 (Treymed, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZC
Too few BZC 510(k)s in any year since 2007 to give a median.
Recalls per year · BZC
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZC
3in 2025
MAUDE reports naming product code BZC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.…
Read the full statement (160 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982487: CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics MO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982487
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026