510(k) · Cleared
ClearedShape-HF Cardiopulmonary 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 Jan 21, 2016 as substantially equivalent to K090722 (Shape Medical Systems, Inc., 2009) and 1 other predicate after a 294-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jan 21, 2016
- Review
- 294 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980094 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK980094 Modification to the OxyconalphaErich Jaeger B.V. · 1998
- 2 generations backK993641 Metalyzer, Model 2; Metalyzer, Model 3Cortex Biophysik GmbH · 2000
- 1 generation backK090722 Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 2009 · Recalled
- This deviceK150888 Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980094 | Modification to the Oxyconalpha | Erich Jaeger B.V. | 1998 | — |
| −2 | 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 |
| 0 (this device) | K150888 | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | 2016 | — |
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? (2)
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 |
|---|---|---|---|
| * | K090722 | Shape-HF Cardiopulmonary Exercise Testing SystemSummary page 4…St. Paul, MN 55127 Telephone: 651- 231-1761 Marketed Device: Shape-HF™ Cardiopulmonary Testing System 510(k) Clearance: K090722 Proprietary Name Modified Device: Shape-HF™ Cardiopulmonary Testing System Common/Usual Name: Cardiopulmonary Exercise Te… | 2009 |
| * | K980094 | Modification to the OxyconalphaSummary page 5…tly marketed device and is substantially equivalent to the following predicate devices: • Shape-HF™ Cardiopulmonary Testing System, K090722 • Jaeger OxyconAlpha, K980094 Reference Table 1 for a summary of Substantial Equivalence Comparison. Technological Characteristics: The modified Shape-HF™ Ca… | 1998 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K090722.
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. 2016, 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-HF™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150888: Shape-HF Cardiopulmonary 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/K150888
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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