Medical Device Manufacturer · CN , Tianjin

Tianjin Huahong Technology Co., Ltd. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2021

Recent clearances: Safety lancet (XL), Lancing device, Huahong Sharps Container (HHR-I, HHR-II)

15
Total
15
Cleared
0
Denied

Tianjin Huahong Technology Co., Ltd. has 15 FDA 510(k) cleared general & plastic surgery devices. Based in Tianjin, CN.

Latest FDA clearance: Sep 2026. Active since 2021.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Landlink Healthcare Technology (Shanghai) Co., Ltd. as regulatory consultant.

FDA 510(k) Regulatory Record - Tianjin Huahong Technology Co., Ltd.

15 devices
1-15 of 15
Cleared Sep 13, 2026
Safety lancet (XL)
K262526 · FMK
General & Plastic Surgery · 53d
Cleared Aug 18, 2026
Lancing device
K262135 · QRL
General & Plastic Surgery · 54d
Cleared Aug 05, 2026
Huahong Sharps Container (HHR-I, HHR-II)
K260845 · MMK
General Hospital · 142d
Cleared Jul 22, 2026
Lancet
K262211 · QRL
General & Plastic Surgery · 22d
Cleared Feb 12, 2026
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
K252490 · FMK
General & Plastic Surgery · 188d
Cleared Dec 09, 2025
Lancing device (HH-XV-T)
K253706 · QRL
General & Plastic Surgery · 15d
Cleared Jun 26, 2025
safety lancet
K251694 · FMK
General & Plastic Surgery · 24d
Cleared Nov 15, 2024
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)
K243306 · QRL
General & Plastic Surgery · 25d
Cleared Jun 20, 2024
Safety Lancet (XXXV)
K241627 · FMK
General & Plastic Surgery · 14d
Cleared May 21, 2024
Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
K240806 · FMK
General & Plastic Surgery · 57d
Cleared Jul 06, 2022
Lancet (I, II, III, V, VI)
K220475 · QRL
General & Plastic Surgery · 138d
Cleared Jul 01, 2022
Insulin Pen Needle
K221176 · FMI
General Hospital · 67d
Cleared May 19, 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · FMK
General & Plastic Surgery · 99d
Cleared May 17, 2022
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
K220372 · FMK
General & Plastic Surgery · 97d
Cleared Nov 12, 2021
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K202319 · FMI
General Hospital · 452d
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