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Sign in to claim this brandStat Medical Devices
US
Last updated May 23, 2026
What Stat Medical Devices makes
Stat Medical Devices manufactures manual blood lancing devices designed for single-use and reusable applications. These devices are intended for controlled skin punctures to facilitate blood sampling, commonly used in diabetes management and clinical testing environments.
The company’s portfolio of blood lancing devices is classified under FDA Class II regulations and is listed in the 510(k) and UDI registries. The manufacturer operates from 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 Stat Medical Devices manufacture?
Stat Medical Devices specializes in manual blood lancing devices, which are tools used to create precise skin punctures for blood sampling. Their portfolio includes both single-use and reusable models, primarily designed for diabetes management and clinical testing environments. These devices are intended to simplify and standardize the process of obtaining blood samples.
Where is Stat Medical Devices based, and what does this mean for its regulatory oversight?
Stat Medical Devices is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s framework. The U.S. regulatory environment ensures that devices like blood lancing systems undergo evaluation to meet safety, performance, and effectiveness standards before being listed in registries such as the 510(k) and UDI systems.
Which regulatory registries list Stat Medical Devices’ blood lancing devices?
Stat Medical Devices’ blood lancing devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. The 510(k) registry documents that the devices have been evaluated for substantial equivalence to a predicate device, while the UDI system ensures traceability and identification of each device type through standardized codes.
How are Stat Medical Devices’ blood lancing devices classified under FDA regulations?
Stat Medical Devices’ blood lancing devices fall under FDA Class II classification. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require premarket notifications (510(k)s) to demonstrate compliance with these controls before being authorized for commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| STAT Medical Devices | LITE Lancing Device | FDA UDI | Class II | Active |
| STAT Medical Devices | Qwik-Lance Safety Lancet | FDA UDI | Class II | Active |
| STAT Medical Devices | TRIO Lancing Device | FDA UDI | Class II | Active |
| STAT Medical Devices | Qwik-Lance Safety Lancet | FDA UDI | Class II | Active |
| STAT Medical Devices | Comfort Thins Twist-Off Lancet | FDA UDI | Class II | Active |
| EasyTouch Lancing Device | K222617 | FDA 510(k) | Class II | Active |
| Super-Fine Pen Needle | K092016 | FDA 510(k) | Class II | Active |
| STAT Medical Device Lancing System | K230310 | FDA 510(k) | Class II | Active |
| ONE DROP Lancing Device | K223815 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Stat Medical Devices has one FDA recall record initiated on 2009-05-29, which is marked as terminated. The recall pertains to Stat Pen Needles with silicone coating, which were not cleared by the FDA for use with that coating, potentially impacting the device’s safety and effectiveness.
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 |
|---|---|---|---|---|
| May 29, 2009 | Z-1596-2009 | — | terminated | Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device. |