Data / Medical devices / United States / Shape Medical Systems, Inc
Shape Medical Systems, Inc: FDA-registered device maker in Saint Paul, MN, United States, 2 510(k) clearances
Shape Medical Systems, Inc is registered with the FDA (registration 3008072932) in Saint Paul, MN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 21, 2016. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008072932
- Address
- MedTech Center/Shape Medical Systems, In 5000 Township Parkway, Saint Paul, MN, United States, 55110
- Owner or operator
- Shape Medical Systems, Inc (10029892)
- Roles
- Manufacturer
- First device listed
- July 10, 2009
- Registered through
- 2026
- Brand names listed
- SHAPE-HF, Shape-HF DRR Testing system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 21, 2016 | K150888 | Shape-HF Cardiopulmonary Testing System | BTY | Substantially Equivalent | Shape Medical Systems, Inc. | accessdata.fda.gov |
| March 31, 2009 | K090722 | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM | BTY | Substantially Equivalent | Shape Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 23, 2014 | 70149 | Class II | Terminated | Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or | 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 approximately 20% with use of the impacted product. | accessdata.fda.gov |
| May 28, 2014 | 68581 | Class II | Terminated | Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise tes | 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 result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. | accessdata.fda.gov |
Compare with other makers
Updated January 21, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.