510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994323Substantially Equivalent

Kawasumi Laboratories Philebotomy Set

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

K994323 is the FDA 510(k) clearance record for KAWASUMI LABORATORIES PHILEBOTOMY SET, a class II device, cleared for Kawasumi Laboratories Co., Ltd. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 29 510(k) clearances for Kawasumi Laboratories Co., Ltd., from to . As of , FDA records show no recalls naming K994323.

Clearance record

Decision date
Received
(77 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
Kawasumi Laboratories Co., Ltd. 1900 K St. NW, Washington DC
510(k) summary
Summary
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