gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

FDA 510(k) K220917 · Gri-Alleset, Inc.

Substantially Equivalent

510(k) numberK220917

Submission

Device name
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
Applicant
Gri-Alleset, Inc.
Flowery Branch, GA, US
Received
March 30, 2022
Decision date
May 18, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4850
Specialty
General, Plastic Surgery

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…

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K260191Safety lancet (XXXVII)FMK · Traditional Tianjin Huahong Technology Co., Ltd.03/31/2026SE
K253605Safety Heel LancetFMK · Traditional Ningbo Medsun Medical Co., Ltd.02/20/2026SE
K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)FMK · Special Tianjin Huahong Technology Co., Ltd.02/12/2026SE
K251694safety lancetFMK · Special Tianjin Huahong Technology Co., Ltd.06/26/2025SE
K244036Heel Incision Safety Lancet (SteriHeel 2)FMK · Traditional SteriLance Medical (Suzhou), Inc.02/26/2025SE
K243533Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusFMK · Traditional Hlb Co., Ltd. Healthcare01/13/2025SE
K242680LetsGetChecked ImpressFMK · Traditional Privapath Diagnostics Ltd (Dba Letsgetchecked)01/13/2025SESU
K242664gentleheel® Adult Incision DeviceFMK · Traditional Gri-Alleset, Inc.11/05/2024SE

More from Gri-Alleset, Inc.

510(k)DeviceDecision
K242664gentleheel® Adult Incision DeviceFMK · Traditional 11/05/2024SE
K210860Comfort Guard Mask, level 1, Comfort Guard Mask, level 3FXX · Traditional 04/07/2022SE
K210131ComfortGuard Surgical Isolation GownFYC · Traditional 08/26/2021SE

Questions and answers

When was gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler cleared by the FDA?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K220917) received a 510(k) decision of Substantially Equivalent on May 18, 2022, 49 days after the submission was received.

What is the product code of K220917?

The FDA product code is FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.