510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K212635Substantially Equivalent

Sofjec

Hwajin Medical Co., Ltd., Cheonan-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212635 is the FDA 510(k) clearance record for Sofjec, a class II device, cleared for Hwajin Medical Co., Ltd. on under FDA product code FMF (Syringe, Piston). FDA records list one 510(k) clearance for Hwajin Medical Co., Ltd. As of , FDA records show no recalls naming K212635.

Clearance record

Decision date
Received
(543 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Hwajin Medical Co., Ltd. 20, Seongsimwon-Gil, Seongnam-Myeon, Dongnam-Gu, Cheonan-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260