Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G, and 30G
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222111 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 Touch Single-Use Safety Lancets are classified as safety lancets under the FDA product code FMK. These devices are designed for obtaining micro blood samples via capillary puncture, featuring a built-in sharps injury prevention mechanism to enhance user safety. Constructed with a stainless steel needle integrated into a plastic holder, they incorporate a pre-loaded steel spring for activation upon skin contact. The range includes five gauge sizes (16G, 21G, 23G, 28G, and 30G) to accommodate varying clinical needs.
These lancets are intended for single-use only and are supplied sterile. Activation occurs through direct skin contact, eliminating the need for manual triggering. They are non-magnetic and MRI-safe, making them suitable for use in magnetic resonance imaging environments. Storage requires protection from moisture and extreme temperatures, adhering to standard sterile device handling protocols. The device holds an FDA 510(k) clearance under the Substantial Equivalence determination (K222111)
Frequently asked questions
What are the Unistik Touch Safety Lancets designed for?
These lancets are specifically engineered for obtaining micro blood samples via capillary puncture, commonly used in clinical settings for glucose monitoring, hematology tests, or other diagnostic procedures requiring small blood volumes. The built-in safety mechanism reduces the risk of needle-stick injuries, making them ideal for frequent or high-volume blood sampling tasks.
How do the Unistik Touch Safety Lancets differ from traditional lancets?
Unlike manual lancets that require pressing a button to activate, the Unistik Touch activates automatically upon direct skin contact due to its pre-loaded steel spring mechanism. This eliminates the need for manual triggering, reducing user error and improving consistency in depth control. The integrated safety feature also retracts the needle after use, minimizing sharps injury risks.
Are these lancets suitable for reuse, or are they single-use only?
These lancets are explicitly designed for single-use only to ensure sterility and patient safety. Reusing them could compromise sterility, increase infection risks, and violate manufacturer guidelines. Each lancet is packaged sterile and intended for one-time use per patient.
What gauge sizes are available, and how do they differ?
The Unistik Touch range includes five gauge sizes: 16G, 21G, 23G, 28G, and 30G. Gauge size correlates inversely with needle thickness—lower numbers (e.g., 16G) produce deeper punctures for larger blood volumes, while higher numbers (e.g., 30G) create shallower punctures for minimal blood sampling. Clinicians select based on patient needs, skin thickness, and the volume of blood required.
How should these lancets be stored to maintain sterility?
Store the lancets in their original packaging, protected from moisture, extreme temperatures, and direct sunlight. Keep them in a clean, dry environment to preserve sterility and functionality. Avoid exposing them to chemicals or contaminants, and adhere to standard sterile device handling protocols to prevent compromise.
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® Touch | Owen Mumford, Unistik® Touch | Owen Mumford, Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G ..., Unistik® Touch Safety Lancets, Owen Mumford - VWR
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222111 | Class II | Active |
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Manufacturer
- Manufacturer
- Owen Mumford Ltd
- FDA Applicant
- Owen Mumford, Ltd.
Sources (1)
- FDA 510(k) K222111 24 fields · synced Oct 5, 2026