510(k) clearances

Safety lancet (XL)

Tianjin Huahong Technology Co., Ltd. · General, Plastic Surgery

K262526Substantially EquivalentTraditionalFMK
Open FDA's page for this record
Third party flag
N
City
Tianjin
Advisory committee description
General, Plastic Surgery
Address 1
A01, Plant B, # 278, Hangkong Rd., Tianjin Pilot Free Trade
Statement or summary
Summary
Product code
FMK
Zip code
300308
Applicant
Tianjin Huahong Technology Co., Ltd.
Decision date
2026-09-13
Decision code
SESE
Country code
CN
Device name
Safety lancet (XL)
Advisory committee
SU
Contact
Ningning Wang
K number
K262526
Date received
2026-07-22
Review advisory committee
SU
Postal code
300308
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Medical specialty description
General, Plastic Surgery
Regulation number
878.4850
Device class
2
Registration number
3021169869, 3008191276, 1417592, 3001452053, 3042871620, 3011420269, 3014312726, 3017210488, 3015209536, 2029275, 3010041511, 3002808145, 3016096098, 3007363438, 3009498548, 3007384659, 3004748528, 3004513970, 2531491, 3001620590, 3007507465, 3026211706, 3005280205, 1058602, 3002680783, 3009109626, 3004168759, 3011191255, 1721183, 3012034017, 3004143450, 3027529701, 2618282, 3043226252, 3006142663, 3030446844, 3038184658, 3002721930, 3003902721, 8021764 +121 more
FEI number
3021169869, 3008191276, 1417592, 3001452053, 3003516723, 3042871620, 3011420269, 3014312726, 3017210488, 3015209536, 3010041511, 3002803444, 3002808145, 3016096098, 3009498548, 3007384659, 3004748528, 3004513970, 3001620590, 3005664575, 3007507465, 3026211706, 3005280205, 3002680783, 3009109626, 3004168759, 3011191255, 3012034017, 3004143450, 3027529701, 3008179438, 3043226252, 3006759904, 3006142663, 3030446844, 3038184658, 3000191104, 3003902721, 3003405786, 3004080548 +121 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.