510(k) · Cleared
ClearedCOSMED K5 Wearable Metabolic Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmed Srl · BZC Calculator, Pulmonary Function Data
Cleared on Jun 20, 2017 as substantially equivalent to K023120 (Erich Jaeger GmbH, 2003) after a 285-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jun 20, 2017
- Review
- 285 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023120 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023120 Oxycon MobileErich Jaeger GmbH · 2003
- This deviceK162515 COSMED K5 Wearable Metabolic TechnologyCosmed Srl · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023120 | Oxycon Mobile | Erich Jaeger GmbH | 2003 | — |
| 0 (this device) | K162515 | COSMED K5 Wearable Metabolic Technology | Cosmed Srl | 2017 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K023120 | Oxycon MobileSummary page 6…with the Cosmed K5 Wearable Metabolic Technology is: Predicate Device: Jaeger Oxycon Mobile Sponsor: SensorMedics, Inc. 510(k) Number: K023120 Clearance Date: 12 November 2003 FDA Product Code: BZC Classification Name: Calculator, Pulmonary Function Da… | 2003 |
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?
- Its one ancestor has no recall.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use. The main measurements reported by the system are Oxygen Uptake, Carbon Dioxide production, Ventilation, Heart Rate and Energy Expenditure. K5 is intended to…
Read the full statement (142 words)
The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use.
The main measurements reported by the system are Oxygen Uptake, Carbon Dioxide production, Ventilation, Heart Rate and Energy Expenditure.
K5 is intended to use with adults and children over the age of 14 years.
It is to be used by physicians or by trained personnel on a physician responsibility.
The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient’s diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162515: COSMED K5 Wearable Metabolic Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162515
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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