510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K083152Substantially Equivalent

Equashield System

Plastmed, Ltd., Tefen Industrial Park, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083152 is the FDA 510(k) clearance record for EQUASHIELD SYSTEM, a class II device, cleared for Plastmed, Ltd. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 2 510(k) clearances for Plastmed, Ltd., from to . As of , FDA records show no recalls naming K083152.

Clearance record

Decision date
Received
(101 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Plastmed, Ltd. Bldg. 7, Tefen Industrial Park, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260