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RIGHTEST Lancing Device GD500

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221062

by Bionime Corporation

Identifiers

510(k) Number
K221062 FDA 510(k)
FDA Product Code
QRL FDA 510(k)

Classification

Device Class
Class 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)

The RIGHTEST Lancing Device GD500 is a multiple-use blood lancet for single-patient use only, designed to obtain capillary blood samples. It is classified as a Class II medical device under FDA regulation 878.4850 and functions by automatically injecting and retracting a sterile lancet into the fingertip to collect blood for diagnostic testing, such as glucose monitoring. The device is intended for one patient only and requires compatible sterile lancets for operation.

This reusable device is intended for use in clinical settings, including general and plastic surgery environments, where controlled blood sampling is required. It is supplied as a non-sterile device but must be used with sterile lancets to ensure patient safety. The device features a depth-adjustable cap for customizable blood sampling depth. Authorised under FDA 510(k) clearance (K221062) and compliant with MDD and MDR standards, it is regulated as a single-patient-use device under the specified product code (QRL).

Frequently asked questions

Is this device intended for home use or is it primarily designed for clinical settings like hospitals or surgery centers?

The RIGHTEST Lancing Device GD500 is designed for clinical settings, including general and plastic surgery environments. While it can be used in controlled environments like hospitals or clinics, it is not explicitly marketed or intended for home use. Its reusable design and depth-adjustable cap are features that align with clinical workflows where multiple patients may require blood sampling under controlled conditions.

How is the device supplied, and what does that mean for its use in a clinical environment?

The RIGHTEST Lancing Device GD500 is supplied as a non-sterile device. However, it is only safe for use when paired with sterile lancets, ensuring patient safety during blood sampling. Clinicians must follow proper sterilization protocols for the device itself if reused across patients, though the device itself is not sterile out-of-the-box. This design ensures compatibility with sterile lancets while allowing the device to be reused within a single patient’s procedure.

Can this device be used with multiple patients, or is it limited to a single patient per device?

The RIGHTEST Lancing Device GD500 is classified as a multiple-use device but is intended for single-patient use only. This means it can be reused within the same patient’s procedure (e.g., for multiple blood samples during surgery) but must not be shared between different patients. This restriction is reinforced by its regulatory classification under product code QRL, which specifies single-patient use.

What regulatory standards does this device comply with, and how does that affect its use in different regions?

The RIGHTEST Lancing Device GD500 is authorized under FDA 510(k) clearance (K221062), as well as compliant with MDD (Medical Device Directive) and MDR (Medical Device Regulation) standards. This means it is approved for use in the U.S. and the European Economic Area (EEA), respectively. Clinicians should verify local regulatory compliance before use, as these standards ensure safety and performance but do not dictate clinical indications.

Does the device come with different sizes or models, and how might that affect its application in clinical procedures?

The device itself is a single model (GD500) but features a depth-adjustable cap, allowing clinicians to customize the blood sampling depth for different patient needs. While the device’s core mechanism remains consistent, the adjustable cap accommodates varying patient requirements—such as pediatric or adult patients—without requiring multiple device models. This flexibility supports its use in diverse clinical settings like general and plastic surgery.

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: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing ..., RIGHTEST Lancing Device GD500, GE Lancing Device… - FDA.report, RIGHTEST Lancing Device GD500, GE Lancing Device… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bionime Corporation

Sources (2)

  • FDA 510(k) K221062 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026