Blood Lancet (K865016)
by Falcon Medical Industries, Inc.
510(k) K865016
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK865016 | Date12 Jan 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Blood Lancet
- 510(k) Number
- FDA Product Code
- FMK
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4850
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Blood Lancet (K865016) is a disposable blood lancet designed for single-use puncture of the skin to obtain a drop of blood for diagnostic testing. It features an integral sharps injury prevention mechanism, ensuring safe operation and immediate inoperability after use. The device is classified under the product code FMK and is intended for clinical settings requiring minimal blood sampling.
This device is supplied as a single-use item, eliminating the need for reprocessing or reuse. It is regulated under FDA 510(k) clearance (K865016) and falls under the advisory committee for General, Plastic Surgery. The lancet is non-sterile as supplied and must be handled according to standard clinical protocols to prevent contamination. No additional regulatory markings or MRI safety considerations are specified.
Questions
AI-generated answers, 19 Sep 2026
What is the Blood Lancet designed for and in what clinical settings is it typically used?
The Blood Lancet (K865016) is specifically designed for single-use puncture of the skin to obtain a small blood sample for diagnostic testing. It is intended for clinical settings where minimal blood sampling is required, such as point-of-care testing, glucose monitoring, or other routine blood tests. Its sharp injury prevention mechanism ensures safe operation, making it suitable for environments where patient and clinician safety are priorities.
Is the Blood Lancet reusable or must it be discarded after use?
The Blood Lancet is explicitly designed as a single-use device. Its disposable nature eliminates the need for reprocessing or reuse, reducing the risk of contamination or cross-infection. After use, the device becomes inoperable due to its built-in sharps injury prevention mechanism, ensuring compliance with safety protocols.
How should the Blood Lancet be stored, and is it sterile as supplied?
The Blood Lancet is non-sterile as supplied, meaning it must be handled according to standard clinical protocols to prevent contamination before use. Storage should follow manufacturer guidelines to maintain its integrity, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for specific storage instructions.
What safety features does the Blood Lancet include to prevent injuries?
The Blood Lancet incorporates an integral sharps injury prevention mechanism, which ensures the device cannot be reused after a single puncture. This design automatically renders the lancet inoperable post-use, significantly reducing the risk of needle-stick injuries for healthcare providers.
What regulatory pathway was followed for FDA clearance of this device?
The Blood Lancet (K865016) received FDA clearance through a Traditional 510(k) pathway, determined to be *substantially equivalent* to a legally marketed predicate device. The submission was reviewed by the General, Plastic Surgery Advisory Committee (SU) under product code FMK, with a clearance decision issued on January 12, 1987.