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510(k) K202319

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) by Tianjin Huahong Technology Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2021
Date Received
August 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Tianjin Huahong Technology Co., Ltd.

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  • K253706 — Lancing device (HH-XV-T) (December 9, 2025)
  • K251694 — safety lancet (June 26, 2025)
  • K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); La (November 15, 2024)
  • K241627 — Safety Lancet (XXXV) (June 20, 2024)
  • K240806 — Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) (May 21, 2024)
  • K220475 — Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T (July 6, 2022)
  • K221176 — Insulin Pen Needle (July 1, 2022)
  • K220370 — Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (May 19, 2022)
  • K220372 — Heel Stick Safety Lancet (HHZ-II, HHZ-III) (May 17, 2022)

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  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
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