510(k) · Cleared
Recalled · Class II · 2014Shape-HF Cardiopulmonary Exercise Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shape Medical Systems, Inc. · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Mar 31, 2009 as substantially equivalent to K993641 (Cortex Biophysik GmbH, 2000) after a 12-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 31, 2009
- Review
- 12 days
- Class
- Class II
- Product code
- BTY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980094 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK980094 Modification to the OxyconalphaErich Jaeger B.V. · 1998
- 1 generation backK993641 Metalyzer, Model 2; Metalyzer, Model 3Cortex Biophysik GmbH · 2000
- This deviceK090722 Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK150888 Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK093080 Metaphor Metabolic MonitorTreymed, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980094 | Modification to the Oxyconalpha | Erich Jaeger B.V. | 1998 | — |
| −1 | K993641 | Metalyzer, Model 2; Metalyzer, Model 3 | Cortex Biophysik GmbH | 2000 | — |
| 0 (this device) | K090722 | Shape-HF Cardiopulmonary Exercise Testing System | Shape Medical Systems, Inc. | 2009 | — |
| +1 | K150888 | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | 2016 | — |
| +1 | K093080 | Metaphor Metabolic Monitor | Treymed, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K993641 | Metalyzer, Model 2; Metalyzer, Model 3Summary page 1…laboratory or clinical conditions. The Shape-HF system is comparable to the Cortex Metalyzer 3BTM system (K993641). The device is software driven and electrically operated. Intended Use: The S… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2014 | Class II | Z-1060-2015 | Under Investigation by firm | This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be… |
| May 28, 2014 | Class II | Z-2051-2014 | Under Investigation by firm | Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150888 (Shape Medical Systems, Inc., 2016) has gone furthest, with 0 descendants of its own.
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. 2009, this device’s year, is highlighted.
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 Shape-HFTM Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090722: Shape-HF Cardiopulmonary Exercise Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090722
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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