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BabyLance Safety Heelstick (BLM, BLN, BLP)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223900

by Clinical Innovations, LLC

Identifiers

510(k) Number
K223900 FDA 510(k)
FDA Product Code
FMK FDA 510(k)
Models / Variants
BLM FDA 510(k)EUDAMED
BLN FDA 510(k)EUDAMED
BLP FDA 510(k)EUDAMED

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 BabyLance Safety Heelstick (BLM, BLN, BLP) is a single-use, spring-loaded incision device designed for neonatal heel sticks. Classified as a safety heelstick device, it is engineered to obtain blood samples from the heel of neonates or infants while incorporating a sharps prevention feature to mitigate needlestick injuries.

This sterile, disposable device is activated via a pendulum-action blade, ensuring an ultra-smooth incision that adheres to CLSI LA4-A5 guidelines for accuracy. Supplied in three sizes—micro-preemie, preemie, and newborn—it is intended for single-use in clinical settings. Authorized under FDA 510(k) clearance (K223900) and MDR compliance, it is intended for use in neonatal care environments.

Frequently asked questions

What sizes are available for the BabyLance Safety Heelstick, and how do I choose the right one for a patient?

The BabyLance Safety Heelstick comes in three sizes: micro-preemie, preemie, and newborn. The sizing is based on the patient’s gestational age or weight to ensure an appropriate incision depth. The micro-preemie size is designed for the smallest neonates, the preemie size for premature infants, and the newborn size for full-term infants. Selecting the correct size helps minimize discomfort and ensures accurate blood sampling while adhering to clinical guidelines.

Is the BabyLance Safety Heelstick reusable, or is it meant for single-use only?

The BabyLance Safety Heelstick is explicitly designed for single-use only. It is a sterile, disposable device, and reusing it could compromise sterility, increase infection risk, or reduce performance. Always use a new device for each procedure to maintain safety and compliance with best practices.

How does the BabyLance Safety Heelstick prevent needlestick injuries, and is it different from traditional heelstick methods?

The BabyLance incorporates a sharps prevention feature through its spring-loaded, pendulum-action blade design. Unlike traditional manual or blade-based heelsticks, this device minimizes exposure risk by containing the blade within the device during activation and use. The blade is fully enclosed, reducing the likelihood of accidental needlestick injuries to healthcare providers.

What storage requirements does the BabyLance Safety Heelstick have, and how should it be handled before use?

Since the BabyLance is a sterile, single-use device, it should be stored in its original packaging until ready for use. The packaging protects sterility, so avoid opening it prematurely or exposing it to contamination. Store in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for integrity before use to ensure sterility is maintained.

What clinical guidelines does the BabyLance Safety Heelstick follow for accuracy in neonatal heelstick procedures?

The BabyLance is engineered to adhere to CLSI LA4-A5 guidelines, which outline best practices for neonatal heelstick procedures. These guidelines emphasize precision in incision depth and technique to ensure reliable blood sampling while minimizing patient discomfort. The device’s pendulum-action blade design helps achieve an ultra-smooth incision, supporting clinical accuracy and consistency.

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: babyLance™ Heelstick - Laborie, babyLance Safety Heelstick (BLM, BLN, BLP) (K223900) — FDA 510 (k ..., PDF babyLance™ Safety Heelstick Product Gui - MediPurpose, BabyLance Safety Heelsticks | Birth International

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clinical Innovations, LLC

Sources (2)

  • FDA 510(k) K223900 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026