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FDA 510(k)

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

K-Number: K252490 · 2026-02-12

ApplicantTianjin Huahong Technology Co., Ltd.
Decision Date2026-02-12
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) is a medical device manufactured by Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-12 under approval number K252490. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)?

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K252490.

When was Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) approved by the FDA?

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) received FDA 510(k) clearance on 2026-02-12, under approval number K252490.

What company makes Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)?

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) is manufactured by Tianjin Huahong Technology Co., Ltd..

What is the FDA product code for Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)?

The FDA product code for Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) is FMK.

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Other Devices by Tianjin Huahong Technology Co., Ltd.

K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) K221176Insulin Pen Needle K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III) K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)

View all 12 devices →

Related Devices (Code: FMK)

K153670Genteel Lancing DeviceGenteel, LLC K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsBecton, Dickinson and Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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