Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K220372 · 2022-05-17

ApplicantTianjin Huahong Technology Co., Ltd.
Decision Date2022-05-17
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Heel Stick Safety Lancet (HHZ-II, HHZ-III) is a medical device manufactured by Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-17 under approval number K220372. 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)?

Heel Stick Safety Lancet (HHZ-II, HHZ-III) is a medical device that received FDA 510(k) clearance on 2022-05-17. It is manufactured by Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K220372.

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

Heel Stick Safety Lancet (HHZ-II, HHZ-III) received FDA 510(k) clearance on 2022-05-17, under approval number K220372.

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

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

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

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

Related Clinical Trials

NCT06984484 Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease RECRUITING

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) 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) K241627Safety Lancet (XXXV)

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.

↑