Home / 510(k) Clearances / K234081

510(k) K234081

RedDrop ONE (One) by Reddrop DX — Product Code FMK

K234081 is an FDA 510(k) premarket notification submitted by Reddrop DX for the device "RedDrop ONE (One)". The FDA issued a decision of SESU on March 21, 2024. The device falls under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850.

Clearance Details

Decision
SESU ()
Decision Date
March 21, 2024
Date Received
December 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class
Class II
Regulation Number
878.4850
Review Panel
SU
Submission Type

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Other clearances for product code FMK

  • K262526 — Safety lancet (XL) (September 13, 2026)
  • K261045 — Verifine Safety Lancets (May 1, 2026)
  • K260191 — Safety lancet (XXXVII) (March 31, 2026)
  • K253605 — Safety Heel Lancet (February 20, 2026)
  • K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (February 12, 2026)
  • K251694 — safety lancet (June 26, 2025)
  • K244036 — Heel Incision Safety Lancet (SteriHeel 2) (February 26, 2025)
  • K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (January 13, 2025)
  • K242680 — LetsGetChecked Impress (January 13, 2025)
  • K242664 — gentleheel® Adult Incision Device (November 5, 2024)

FDA data resources