SafetiCET Safety Lancet
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SafetiCET EUDAMED
- Device Name
- SafetiCET EUDAMED
- Model / Reference
- SC-220 EUDAMEDSC-250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08887629000343 EUDAMED
- Basic UDI-DI
- 8887629SC4N EUDAMED
- Unit of Use DI
- 08887629000312 EUDAMED
- 510(k) Number
- K221783 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The SafetiCET Safety Lancet SC-150 is a contact-activated safety lancet designed for capillary blood sampling. It is classified as a safety lancet and is intended for single-use, reducing the risk of needle-stick injuries while facilitating efficient blood collection. The device features a compact, lightweight design optimized for patient comfort and ease of use. Its 1.5 mm depth setting ensures controlled penetration for reliable sampling.
This single-use, non-sterile device is supplied in a sterile package for immediate clinical use. It is intended for use in outpatient settings, including general and plastic surgery environments, where capillary blood sampling is required. The lancet is not MRI-compatible and must be disposed of after one use to maintain safety standards. Authorized under FDA 510(k) clearance and MDR compliance, it adheres to regulatory standards for safety and performance in medical settings.
Frequently asked questions
What types of clinical settings is the SafetiCET Safety Lancet intended for, and why is it particularly useful there?
The SafetiCET Safety Lancet SC-150 is designed for outpatient settings, including general and plastic surgery environments, where capillary blood sampling is required. Its compact, lightweight design and controlled 1.5 mm penetration depth make it ideal for these settings, as it ensures patient comfort while providing reliable blood collection. The single-use, safety lancet design also minimizes the risk of needle-stick injuries, which is critical in busy clinical environments where infection control is paramount.
Is the SafetiCET Safety Lancet sterile, and how is it packaged for clinical use?
The SafetiCET Safety Lancet is supplied in a sterile package, ensuring it is ready for immediate clinical use upon opening. However, the device itself is classified as non-sterile, which means it is not intended for sterile procedures or invasive applications beyond capillary blood sampling. The sterile packaging is designed to maintain its integrity until the first use.
How many times can the SafetiCET Safety Lancet be used, and what should be done with it after use?
The SafetiCET Safety Lancet is explicitly designed for single-use only to prevent needle-stick injuries and ensure patient safety. After a single use, it must be disposed of immediately in accordance with standard biohazard waste protocols. Reusing the device would violate its intended safety design and regulatory compliance.
Can the SafetiCET Safety Lancet be used in an MRI environment, and why?
No, the SafetiCET Safety Lancet is not MRI-compatible. This means it should not be used in or near an MRI machine, as metallic components could pose a risk to patients or interfere with imaging. The device’s design prioritizes safety for blood sampling outside MRI environments, such as in outpatient clinics or surgery settings.
What regulatory pathways does the SafetiCET Safety Lancet follow, and what does that mean for its use?
The SafetiCET Safety Lancet has been authorized through FDA 510(k) clearance and MDR compliance, meaning it meets regulatory standards for safety and performance in the U.S. and European markets. This clearance confirms that the device has been evaluated for substantial equivalence to a predicate device and adheres to manufacturing, design, and performance requirements. Clinicians can rely on its regulatory backing for use in capillary blood sampling as described.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SAFETiCET™ SC-150, 1.5mm depth - NSP Tech, Safety lancet - SAFETiCET™ SC-150 - NSP Tech Pte Ltd - MedicalExpo, Safeticet - NSP Tech Pte Ltd - PDF Catalogs - MedicalExpo
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221783 | Class II | Active |
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Manufacturer
- Manufacturer
- Nsp Tech Pte, Ltd.
Sources (2)
- FDA 510(k) K221783 24 fields · synced Sep 18, 2026
- EUDAMED 24665ddf-d59a-4d21-9750-8300b0f0da20 61 fields · synced Jul 21, 2026