SureLite and SureLite XL Blood Lancet

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K902416 ↗

FDA Product Code

FMK

Device Class

Class II

Regulation

21 CFR Part 878.4850

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Carelet Safety Lancet

  Class II

  FDA 510(k) K931828 Active Cleared 15 Oct 1993

• I.V. Priming Set

  Class II

  FDA 510(k) K913333 Active Cleared 23 Oct 1991

• Sureseal Bandage

  Class I

  FDA 510(k) K922441 Active Cleared 10 Aug 1993

• Needle, Aspiration & Injection, Disposable

  Class II

  FDA 510(k) K902422 Active Cleared 6 Jun 1991

• Cleanlet, Cleanlet Xl & Kids

  Class II

  FDA 510(k) K931827 Active Cleared 13 Sep 1993

• Catheter, Nasal, Oxygen

  Class I

  FDA 510(k) K902420 Active Cleared 17 Apr 1991

See all devices from Gainor Medical Europe, Ltd. →

• What are the primary clinical settings where the SureLite and SureLite XL Blood Lancet is used?

  The SureLite and SureLite XL Blood Lancet is designed for use in general and plastic surgery settings. It provides a controlled way to obtain capillary blood samples through percutaneous skin puncture, making it suitable for diagnostic testing or patient monitoring in these clinical environments.

• Are the SureLite and SureLite XL Blood Lancets intended for reuse, or are they single-use devices?

  The SureLite and SureLite XL Blood Lancets are explicitly labeled as single-use devices. Each lancet is intended for one-time use per patient to ensure sterility and safety, adhering to standard sterile disposable protocols.

• How should I store the SureLite and SureLite XL Blood Lancets before use to maintain their sterility?

  Since these lancets are sterile and disposable, storage should follow standard sterile disposable protocols. This typically means keeping them in their original packaging until use, ensuring the packaging remains intact and uncontaminated to preserve sterility.

• What regulatory pathway was followed for FDA clearance of the SureLite and SureLite XL Blood Lancets?

  The SureLite and SureLite XL Blood Lancets were cleared through the FDA’s 510(k) process, specifically under a Traditional clearance route. They were determined to be substantially equivalent to a predicate device and fall under product code FMK, which categorizes them as disposable lancets for skin puncture.