Carelet Safety Lancet

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K931828 ↗

FDA Product Code

FMK

Device Class

Class II

Regulation

21 CFR Part 878.4850

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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

• SureLite and SureLite XL Blood Lancet

  Class II

  FDA 510(k) K902416 Active Cleared 1 Aug 1990

See all devices from Gainor Medical Europe, Ltd. →