510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K950178Substantially Equivalent

Pharma-Plast Pureline(tm) Comfort(tm) & Clini Sofs Plus Subcutaneous Infusion Set

Pharma-Plast Intl. A/S, Londonderry NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950178 is the FDA 510(k) clearance record for PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET, a class I device, cleared for Pharma-Plast Intl. A/S on under FDA product code LZE (Isometer). FDA records list 2 510(k) clearances for Pharma-Plast Intl. A/S, from to . As of , FDA records show no recalls naming K950178.

Clearance record

Decision date
Received
(181 days to decision)
Product code
LZE Isometer
Regulation
21 CFR 888.1520
Device class
Class I
Review panel
Orthopedic
Applicant
Pharma-Plast Intl. A/S 32 Hemlock St., Londonderry NH
510(k) summary
Summary
Third party review
No

Clearances, product code LZE

Trailing 12 months

FDA records hold no clearances under product code LZE in the trailing twelve months.

FDA records show no clearances under product code LZE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260