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Disposable Safety Lancets

by Huaian Hening Medical Instruments Co., Ltd.

510(k) K223313

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223313 Date23 Jan 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMK
Device Class
Class II
Regulation
21 CFR Part 878.4850
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Disposable Safety Lancets are a type of medical device designed for capillary blood sampling. They are intended to puncture the skin to obtain a small blood sample for diagnostic testing.

These lancets are supplied as sterile, single-use devices. They are used in clinical and point-of-care settings for procedures such as glucose monitoring. The device has received FDA 510(k) clearance under product code FMK and is classified as substantially equivalent to a legally marketed predicate device.

Other devices from Huaian Hening Medical Instruments Co., Ltd.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Disposable Safety Lancets used for?

    Disposable Safety Lancets are designed for capillary blood sampling to obtain a small blood sample for diagnostic testing, such as glucose monitoring in clinical and point-of-care settings.

  • Are Disposable Safety Lancets sterile and single-use?

    Yes, Disposable Safety Lancets are supplied as sterile, single-use devices, meaning each lancet is intended for one use only to maintain sterility and prevent cross-contamination.

  • What regulatory clearance do Disposable Safety Lancets have?

    Disposable Safety Lancets have received FDA 510(k) clearance under product code FMK, demonstrating they are substantially equivalent to a legally marketed predicate device.