510(k) · Cleared
ClearedMetaphor Metabolic Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Treymed, Inc. · BZL Computer, Oxygen-Uptake
Cleared on Jan 22, 2010 as substantially equivalent to K051092 (GE Healthcare, 2005) and 4 other predicates after a 114-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jan 22, 2010
- Review
- 114 days
- Class
- Class II
- Product code
- BZL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K000126 (2000). 15 ancestors in all, the oldest K955432 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 3 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 2 generations backK040214 Modification to: Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2004
- 1 generation backK083705 Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc. · 2009
- This deviceK093080 Metaphor Metabolic MonitorTreymed, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −3 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −2 | K040214 | Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2004 | — |
| −1 | K083705 | Bci WW1020 Pulse Oximeter, Model WW1020 | Smiths Medical Pm, Inc. | 2009 | — |
| 0 (this device) | K093080 | Metaphor Metabolic Monitor | Treymed, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZL? 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 BZL device
- #1 K190561 NICU V'02score 2.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…Summary page 1…868.1700 BZK 21 CFR §868.1850 Class: Class II (3) Predicate Device(s): K051092 Datex-Ohmeda S/S Compact Airway Module (Model Family E-CAIOVX), GE HealthCare K955432 M… | 2005 |
| * | K955432 | CPX, CCM, Cath with 15% CO2Summary page 1…I (3) Predicate Device(s): K051092 Datex-Ohmeda S/S Compact Airway Module (Model Family E-CAIOVX), GE HealthCare K955432 MedGraphics CPX/D with Breeze EX software; Medical Graphics Corporation… | 1996 |
| * | K982487 | CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor…Summary page 2…Graphics Corporation 5-I Page 2 of 4 K982487 Meteor Hand Held Respiratory Mechanics Monitor, TreyMed', Inc. (formerly CardioPulmonary Technologies, In… | 1998 |
| * | K083705 | Bci WW1020 Pulse Oximeter, Model WW1020Summary page 2…Page 2 of 4 K982487 Meteor Hand Held Respiratory Mechanics Monitor, TreyMed', Inc. (formerly CardioPulmonary Technologies, Inc.) K083705 BCI WW1O2O SPECTRO2 Pulse Oximeter, Smiths Medical PM, Inc. (formerly BCI) K090722 Shape-HF Ca… | 2009 |
| * | K090722 | Shape-HF Cardiopulmonary Exercise Testing SystemSummary page 2…Inc. (formerly CardioPulmonary Technologies, Inc.) K083705 BCI WW1O2O SPECTRO2 Pulse Oximeter, Smiths Medical PM, Inc. (formerly BCI) K090722 Shape-HF Cardiopulmonary Exercise Testing System, Shape Medical Systems, Inc. Reason for Submission… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 7 other devices also cite its predicate K051092.
How does its category compare?
All BZL devicesBZL Computer, Oxygen-Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · BZL
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · BZL
Too few BZL 510(k)s in any year since 2007 to give a median.
Recalls per year · BZL
No recall names BZL since 2007.
Adverse event reports per year · BZL
1in 2023
MAUDE reports naming product code BZL, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (125 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093080: Metaphor Metabolic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093080
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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