Cleared Special

K252490 - Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252490 · Tianjin Huahong Technology Co., Ltd. · General & Plastic Surgery device
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Feb 2026
Decision
188d
Days
Class 2
Risk

K252490 is an FDA 510(k) clearance for the Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV). Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Tianjin Huahong Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on February 12, 2026 after a review of 188 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4850 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tianjin Huahong Technology Co., Ltd. devices

Submission Details

510(k) Number K252490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2025
Decision Date February 12, 2026
Days to Decision 188 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 114d · This submission: 188d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 108
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K252490.
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K261045 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
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K253605 · Ningbo Medsun Medical Co., Ltd. · Feb 2026
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K251694 · Tianjin Huahong Technology Co., Ltd. · Jun 2025
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LetsGetChecked Impress
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