510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K030604Substantially Equivalent

Perfect Safety Syringe

Perfect Medical Industry Co., Ltd., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K030604 is the FDA 510(k) clearance record for PERFECT SAFETY SYRINGE, a class II device, cleared for Perfect Medical Industry Co., Ltd. on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Perfect Medical Industry Co., Ltd. As of , FDA records show no recalls naming K030604.

Clearance record

Decision date
Received
(430 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Perfect Medical Industry Co., Ltd. 6833 Saint Lawrence St., Plano TX
510(k) summary
Statement
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260