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BD Microtainer® Contact-Activated Lancets - BD Microtainer® Quikheel™ Lancets

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223243Ref 365964Ref 363707Ref 368933Ref 365993

by Becton, Dickinson and Company

Identity

Trade Name
Microtainer EUDAMED
Device Name
BD Microtainer® Blood Collection Tubes EUDAMED
BD Microtainer® Blood Collection Tube Extender EUDAMED
Model / Reference
365964 EUDAMED
363707 EUDAMED
368933 EUDAMED
365993 EUDAMED

Identifiers

Primary DI / UDI-DI
30382903659648 EUDAMED
00382903637072 EUDAMED
30382903689331 EUDAMED
30382903659938 EUDAMED
Basic UDI-DI
038290NWQEDLUVKA EUDAMED
038290PGYHYFTAJH EUDAMED
Unit of Use DI
00382903659647 EUDAMED
00382903689330 EUDAMED
00382903659937 EUDAMED
510(k) Number
K223243 FDA 510(k)
FDA Product Code
FMK FDA 510(k)
EMDN Code
W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMED
W0501010280 CAPILLARY BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
Models / Variants
BD Microtainer® Quikheel™ Lancets FDA 510(k)EUDAMED

Classification

Device Class
Class A EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4850 FDA 510(k)
Regulation Number
878.4850 FDA 510(k)
Market of Registration
Belgium EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

The BD Microtainer Contact-Activated Lancets and BD Microtainer Quikheel Lancets are single-use, disposable lancets designed for blood collection. These devices are intended for percutaneous skin puncture to obtain capillary blood samples, commonly used in point-of-care testing and laboratory diagnostics.

These lancets are supplied sterile and intended for single-use only, ensuring patient safety and minimizing infection risk. They are classified under product code FMK and have received FDA 510(k) clearance, IVDR, and MDR authorizations. The devices are packaged individually for convenience and must be stored in a clean, dry environment prior to use.

Frequently asked questions

Are these lancets reusable or designed for single-use, and why does that matter for patient safety?

These lancets are intended for single-use only, as explicitly stated in the device description. This design ensures patient safety by minimizing infection risk, as reuse could introduce contamination from previous use. Single-use also reduces the risk of cross-contamination between patients, aligning with best practices for sterile medical devices in blood collection.

How should I store these lancets before use, and what happens if they’re exposed to moisture?

The packaging instructions specify storage in a clean, dry environment prior to use. Exposure to moisture could compromise sterility, as moisture may alter the integrity of the packaging or the lancet itself. Ensuring a dry storage area helps maintain the device’s sterile condition, which is critical for reliable blood collection and infection prevention.

What types of blood collection procedures are these lancets most commonly used for?

These lancets are designed for percutaneous skin puncture to obtain capillary blood samples, which are commonly used in point-of-care testing (e.g., glucose monitoring, rapid infectious disease testing) and laboratory diagnostics. Their compact, single-use design makes them ideal for quick, low-volume blood draws in settings like clinics, hospitals, or home healthcare.

Are these lancets available in multiple sizes or models, and if so, how would I know which one to select?

The provided data does not specify individual sizes or models beyond the two product lines (Contact-Activated and Quikheel). Selection would typically depend on clinical needs—such as depth of puncture required or patient comfort—but the manufacturer’s documentation or sales team would provide guidance on compatibility with specific collection tubes or devices. Always verify compatibility with your intended use case.

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: Becton Dickinson – Wikipedia, BD (company) - Wikipedia

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Sources (5)

  • FDA 510(k) K223243 24 fields · synced Oct 6, 2026
  • EUDAMED 7644a72b-9259-460a-bbc7-f2506de8783a 61 fields · synced Jul 9, 2026
  • EUDAMED 8fed84e9-8cb9-456b-a02a-f8365f424162 61 fields · synced Jul 12, 2026
  • EUDAMED f4c80b4a-2453-45c6-af2e-470910087274 61 fields · synced Jul 16, 2026
  • EUDAMED 24aa8746-2ce9-459b-8939-bc89d3774031 61 fields · synced Jul 27, 2026