510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993017Substantially Equivalent

Profi Disposable Syringe, Profi Disposable Needle, Dm Ject Insulin Syringe

ShinChang Medical Co., Ltd., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993017 is the FDA 510(k) clearance record for PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE, a class II device, cleared for Shinchang Medical Co., Ltd. on under FDA product code FMF (Syringe, Piston). FDA records list 3 510(k) clearances for Shinchang Medical Co., Ltd., from to . As of , FDA records show 8 recalls naming K993017.

Clearance record

Decision date
Received
(170 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Shinchang Medical Co., Ltd. 3762 S. 150 E., Salt Lake City UT
510(k) summary
Statement
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