# K093080: Metaphor Metabolic Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Treymed, Inc.
- Decided: Jan 22, 2010 after 114 days
- Product code: BZL (Computer, Oxygen-Uptake)
- Device class: 2
- Regulation: 21 CFR 868.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000126 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc, GE Healthcare (2005) Summary page 1.
- K955432: CPX, CCM, Cath with 15% CO2, Medical Graphics Corp. (1996) Summary page 1.
- K982487: CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor Hand Held Respiratory Mechanics MO, Cardiopulmonary Technologies, Inc. (1998) Summary page 2.
- K083705: Bci WW1020 Pulse Oximeter, Model WW1020, Smiths Medical Pm, Inc. (2009) Summary page 2.
- K090722: Shape-HF Cardiopulmonary Exercise Testing System, Shape Medical Systems, Inc. (2009) Summary page 2.

## Indications for use
The Metaphor uses the direct measurement of Oxygen uptake (00O2) and Carbon Dioxide productionO(CO2) to objectively and noninvasively assess breath by breath metabolic function durnn g rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional measurement of Nitrous Oxide (N 20) is available for enhanced accuracy of the CO, measurement in the presence of N 20. The Metaphor is a comprehensive, pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously. The Metaphor pulse oximetry function provides continuous SpO 2 and pulse rate measurements in neonatal through adult populations with appropriate probes. The Metaphor pmovides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.

Source page: https://510kreport.com/device/K093080
Methodology: https://510kreport.com/methodology