Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222168 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 Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets are spring-powered, single-use lancets designed for heel incision procedures in neonatal and pediatric patients. These devices provide a controlled, precise incision to facilitate blood sampling in preterm (MicroPreemie, Preemie), full-term infants, and toddlers, with an integrated safety mechanism to minimize needlestick risks.
Intended for sterile clinical use, these lancets are supplied individually packaged and are not reusable. The devices feature a trigger-activated mechanism with automatic blade sweeping and self-disabling after single use. Authorized under FDA 510(k) and MDR, they are categorized under product code FMK and reviewed by the General Plastic Surgery Advisory Committee.
Frequently asked questions
What patient sizes or age groups are these lancets specifically designed for, and how does that differ from standard heel lancets?
These lancets are tailored for neonatal and pediatric patients, including MicroPreemie, Preemie, Full-Term infants, and toddlers. Unlike standard heel lancets, they are engineered with precise, controlled incisions to accommodate the smaller and more delicate heel sites of these age groups, ensuring safer and more effective blood sampling.
Are these lancets reusable, and if not, how are they packaged to maintain sterility?
No, these lancets are explicitly designed for single-use only and are supplied individually in sterile packaging to ensure sterility. Each unit is sealed to prevent contamination, making them safe for one-time clinical use without risk of cross-infection.
How does the safety mechanism work, and why is it important for heel incision procedures?
The lancets feature a trigger-activated mechanism with automatic blade sweeping, which retracts the blade after use, eliminating the risk of accidental needlestick injuries. This is critical in clinical settings where heel sticks are performed on vulnerable patients, as it reduces exposure to bloodborne pathogens for healthcare providers.
What regulatory pathways have these lancets undergone, and which advisory committee reviewed their submission?
These lancets were authorized through the FDA 510(k) pathway (traditional clearance) and the EU MDR, with a substantially equivalent determination. Their submission was reviewed by the General Plastic Surgery Advisory Committee (SU) under product code FMK, ensuring compliance with safety and performance standards for surgical devices.
Are there different models for varying patient sizes, and if so, how do they differ?
Yes, the product line includes four models: MicroPreemie, Preemie, Full-Term, and Toddler, each designed to match the heel size and incision requirements of those specific patient groups. The differences lie in the blade depth and incision precision, ensuring optimal blood sampling without excessive tissue damage.
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: Unistik® TinyTouch™ | Owen Mumford, Unistik® TinyTouch™ | Owen Mumford, Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets ..., Unistik Tinytouch Sterile Single-use Heel Incision Safety Lancets ...
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 | K222168 | Class II | Active |
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Manufacturer
- Manufacturer
- Owen Mumford Ltd
- FDA Applicant
- Owen Mumford, Ltd.
Sources (2)
- FDA 510(k) K222168 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026