510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930012Substantially Equivalent

Kawasumi Laboratories K-Cuff

Kawasumi Laboratories Co., Ltd., Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930012 is the FDA 510(k) clearance record for KAWASUMI LABORATORIES K-CUFF, a class I device, cleared for Kawasumi Laboratories Co., Ltd. on under FDA product code KZD (Infusor, Pressure, For I.V. Bags). FDA records list 29 510(k) clearances for Kawasumi Laboratories Co., Ltd., from to . As of , FDA records show no recalls naming K930012.

Clearance record

Decision date
Received
(344 days to decision)
Product code
KZD Infusor, Pressure, For I.V. Bags
Regulation
21 CFR 880.5420
Device class
Class I
Review panel
General Hospital
Applicant
Kawasumi Laboratories Co., Ltd. Kawasumi Bldg. 3-28-15, Tokyo, JP
510(k) summary
Summary
Third party review
No

Clearances, product code KZD

Trailing 12 months

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

FDA records show no clearances under product code KZD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZD, 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