510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061197Substantially Equivalent

Kawasumi Laboratories Empty Solution Container

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

K061197 is the FDA 510(k) clearance record for KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER, a class II device, cleared for Kawasumi Laboratories, Inc. on under FDA product code KPE (Container, I.V.). FDA records list 29 510(k) clearances for Kawasumi Laboratories, Inc., from to . As of , FDA records show no recalls naming K061197.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
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 KPE

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