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FDA 510(k)

Safety lancet (XXXVII)

K-Number: K260191 · 2026-03-31

ApplicantTianjin Huahong Technology Co., Ltd.
Decision Date2026-03-31
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Safety lancet (XXXVII) is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-31 under 510(k) number K260191. 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 Safety lancet (XXXVII)?

Safety lancet (XXXVII) is a medical device that received FDA 510(k) clearance on 2026-03-31. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K260191.

When did Safety lancet (XXXVII) receive FDA 510(k) clearance?

Safety lancet (XXXVII) received FDA 510(k) clearance on 2026-03-31, under 510(k) number K260191.

Who is the listed applicant for Safety lancet (XXXVII)?

The FDA 510(k) record lists Tianjin Huahong Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety lancet (XXXVII)?

The FDA product code for Safety lancet (XXXVII) is FMK.

Other records listing Tianjin Huahong Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260845Huahong Sharps Container (HHR-I, HHR-II)K262211LancetK252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)K253706Lancing device (HH-XV-T)K251694safety lancetK243306Lancet (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 14 devices →

Related Devices (Code: FMK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.K243533Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare

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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