Heel Incision Safety Lancet (SteriHeel 2)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K244036 FDA 510(k)
- FDA Product Code
- FMK 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 Heel Incision Safety Lancet (SteriHeel 2) is a single-use, sterile disposable device classified as a safety lancet for heel puncture. It is designed to facilitate controlled, precise blood collection from the heel of newborns, including preterm infants, by creating a small incision with minimal trauma. The device is engineered to reduce pain and bleeding while ensuring a sufficient sample volume for diagnostic testing.
This lancet is supplied as a sterile, single-use device intended for use in clinical settings such as hospitals, newborn screening centers, and pediatric care units. It is regulated under FDA 510(k) clearance (K244036) and the EU Medical Device Regulation (MDR), with a product code of FMK. The device is non-magnetic and does not require special storage conditions beyond standard sterile supply protocols.
Frequently asked questions
What clinical settings is the SteriHeel 2 designed for use in, and why is it particularly suited for newborns and preterm infants?
The SteriHeel 2 is designed for clinical settings like hospitals, newborn screening centers, and pediatric care units. It is specifically engineered for heel puncture on newborns, including preterm infants, to create a controlled incision with minimal trauma. This reduces pain and bleeding while ensuring a sufficient blood sample volume for diagnostic testing, making it ideal for delicate procedures on infants.
Is the SteriHeel 2 reusable, and if not, what are the implications for storage and handling?
No, the SteriHeel 2 is a single-use, sterile disposable device. This means each unit is intended for one-time use only, and proper sterile supply protocols must be followed for storage and handling to maintain sterility and prevent contamination.
What special storage conditions, if any, are required for the SteriHeel 2, and why?
The SteriHeel 2 does not require special storage conditions beyond standard sterile supply protocols. This is because the device is designed to be stored under typical clinical sterile conditions, ensuring its integrity and sterility until use.
What regulatory pathways has the SteriHeel 2 followed, and what does this mean for its use in the U.S. and EU markets?
The SteriHeel 2 has obtained FDA 510(k) clearance (K244036) and EU Medical Device Regulation (MDR) authorization. In the U.S., this clearance confirms the device is substantially equivalent to a predicate and meets FDA safety and performance requirements. In the EU, MDR compliance ensures it adheres to stringent regulatory standards for medical devices, allowing its legal use in clinical settings across the region.
How does the SteriHeel 2 differ from traditional heel puncture devices in terms of pain and bleeding reduction?
The SteriHeel 2 is engineered to create a precise, controlled incision rather than a puncture, which helps minimize trauma to the heel. This design reduces both pain and bleeding compared to traditional lancets, ensuring a more comfortable experience for newborns and preterm infants while still providing an adequate blood sample for testing.
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: Heel Incision Safety Lancet (SteriHeel 2) (K244036) — FDA 510(k ..., SteriHeel Plus - SteriLance Medical (Suzhou) Inc., Heel Incision Safety Lancet (SteriHeel 2) 510(k)… - FDA.report
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 | K244036 | Class II | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- FDA Applicant
- SteriLance Medical (Suzhou), Inc.
Sources (2)
- FDA 510(k) K244036 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026