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Sign in to claim this brandShape Medical Systems, Inc.
US
Last updated May 23, 2026
What Shape Medical Systems, Inc. makes
The company produces pulmonary function analysis systems and testing kits designed for adult patients, including disposable patient interfaces with filters and systems for cardiopulmonary exercise testing. Their portfolio includes standalone devices like the Shape Vital Sign System and refurbished versions of the Shape II System, as well as specialized systems for assessing heart failure (Shape-HF).
These devices are classified as Class II under FDA regulations and are authorised through 510(k) clearance and the FDA’s Unique Device Identification (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shape Medical Systems, Inc. manufacture?
Shape Medical Systems, Inc. specializes in pulmonary function analysis systems and testing kits for adult patients. Their products include standalone devices like the Shape Vital Sign System, as well as specialized systems for cardiopulmonary exercise testing, such as the Shape-HF and SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM. They also produce disposable patient interfaces with filters and refurbished versions of systems like the Shape II. These devices focus on assessing lung and heart function, particularly in conditions like heart failure.
Where is Shape Medical Systems, Inc. based?
Shape Medical Systems, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under FDA guidelines for device authorization.
How are Shape Medical Systems, Inc.’s devices classified under FDA regulations?
Shape Medical Systems, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to most of their pulmonary function analysis systems and testing kits, which are considered to pose moderate risk and require special controls to ensure safety and effectiveness. Class II devices are authorised through the 510(k) clearance process, demonstrating substantial equivalence to a legally marketed predicate device, and are also tracked via the FDA’s Unique Device Identification (UDI) system for traceability.
Which regulatory registries or databases list Shape Medical Systems, Inc.’s devices?
Shape Medical Systems, Inc.’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identification (UDI) system. These registries are critical for tracking device authorizations, ensuring transparency in the medical device market, and verifying compliance with FDA requirements. The 510(k) database confirms that individual devices have undergone the clearance process, while the UDI system provides a standardized identifier for traceability and recall management.
What is the purpose of the specialized systems like Shape-HF in Shape Medical Systems, Inc.’s portfolio?
The Shape-HF systems are designed specifically for cardiopulmonary exercise testing in patients with heart failure (HF). These devices expand on standard pulmonary function analysis by integrating heart function assessments, allowing clinicians to evaluate how a patient’s heart and lungs interact during physical exertion. This helps in diagnosing, monitoring, and managing heart failure more comprehensively than general pulmonary testing alone.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 021315587
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Patient Interface with filter | 0004-4012 | FDA UDI | Class II | Active |
| Shape Vital Sign System | 0008-3012 | FDA UDI | Class II | Active |
| Shape-HF | Disposable Patient Interface | FDA UDI | Class II | Active |
| Shape-HF | 0008-9001 | FDA UDI | Class II | Active |
| Shape II System Refurbished | 0012-9012 | FDA UDI | Class II | Active |
| Shape | HF012 | FDA UDI | Class II | Active |
| Shape | Shape | FDA UDI | Class II | Active |
| Shape-HF | HF001 | FDA UDI | Class II | Active |
| Shape-HF Cardiopulmonary Testing System | K150888 | FDA 510(k) | Class II | Active |
| Shape-Hf Cardiopulmonary Exercise Testing System | K090722 | FDA 510(k) | Class II | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Shape Medical Systems, Inc. has two recall records, both initiated in 2014—one on May 28 and the other on December 23. Both recalls were terminated, involving the Shape HF Cardiopulmonary Testing System. The first was a correction for a mandatory software upgrade affecting specific DPI lot numbers, while the second was initiated due to potential erroneous testing results from those impacted lots, which could affect VO2 or VCO2 parameters by up to 20%.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 23, 2014 | Z-1060-2015 | — | terminated | 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. |
| May 28, 2014 | Z-2051-2014 | — | terminated | 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. |