510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820742Substantially Equivalent

Nihon Kohden Blood Flowmeters #Mfv-1100

Nihon Kohden America Inc, Foothill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820742 is the FDA 510(k) clearance record for NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K820742.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Nihon Kohden America, Inc. 90 Icon St., Foothill CA
Third party review
No

Clearances, product code DPW

Trailing 12 months
3 clearances under product code DPW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260