510(k) · Cleared
ClearedMetalyzer, Model 2; Metalyzer, Model 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortex Biophysik GmbH · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Dec 14, 2000 as substantially equivalent to K980094 (Erich Jaeger B.V., 1998) after a 413-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Dec 14, 2000
- Review
- 413 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980094 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK980094 Modification to the OxyconalphaErich Jaeger B.V. · 1998
- This deviceK993641 Metalyzer, Model 2; Metalyzer, Model 3Cortex Biophysik GmbH · 2000
- Descendant · cites it directly · 2 of its ownK090722 Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK150888 Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK093080 Metaphor Metabolic MonitorTreymed, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K090722Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 2009 · cites it directly2descendants
- K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. · 2016 · 2 generations on0descendants
- K093080Metaphor Metabolic MonitorTreymed, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980094 | Modification to the Oxyconalpha | Erich Jaeger B.V. | 1998 | — |
| 0 (this device) | K993641 | Metalyzer, Model 2; Metalyzer, Model 3 | Cortex Biophysik GmbH | 2000 | — |
| +1 | K090722 | Shape-HF Cardiopulmonary Exercise Testing System | Shape Medical Systems, Inc. | 2009 | 2 |
| +2 | K150888 | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | 2016 | — |
| +2 | K093080 | Metaphor Metabolic Monitor | Treymed, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 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 BTY? 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 BTY device
- #1 K260242 CPETWise Platformscore 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K980094 | Modification to the OxyconalphaSummary page 1…ch, FL 33572 Phone: 813-287-2382 Fax: 813-287-8866 Art Ward September 1, 1999 CORTEX METALYZER Predictive Pulmonary Function Value Calculator 21 CFR Section 868.1890 K980094 Oxycon Alpha Jaeger The CORTEX METALYZER metabolic test system is a stationary device, which can monitor parameters during labor… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090722 | Shape-HF Cardiopulmonary Exercise Testing System | 2009 | 2 |
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?
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, 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 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CORTEX METALYZER pulmonary function stationary test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The METALYZER system provides predictive pulmonary function values using the monitored and derived parameters. This device is for use in a laboratory or facility setting and may be used with adults and children over the age of 14 years.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993641: Metalyzer, Model 2; Metalyzer, Model 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993641
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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