510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100720Substantially Equivalent

K-Shield Port Access Infusion Set with High Pressure Tubing

Kawasumi Laboratories Co., Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100720 is the FDA 510(k) clearance record for K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING, a class II device, cleared for Kawasumi Laboratories, Inc. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 29 510(k) clearances for Kawasumi Laboratories, Inc., from to . As of , FDA records show one recall naming K100720.

Clearance record

Decision date
Received
(248 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Kawasumi Laboratories, Inc. 1601 K St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA 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 FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260