510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843836Substantially Equivalent

Thermal Grayscale RF-100

Fukuda Denshi USA, Inc., Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843836 is the FDA 510(k) clearance record for THERMAL GRAYSCALE RF-100, a class I device, cleared for Fukuda Denshi USA, Inc. on under FDA product code DSF (Recorder, Paper Chart). FDA records list 68 510(k) clearances for Fukuda Denshi USA, Inc., from to . As of , FDA records show no recalls naming K843836.

Clearance record

Decision date
Received
(18 days to decision)
Product code
DSF Recorder, Paper Chart
Regulation
21 CFR 870.2810
Device class
Class I
Review panel
Cardiovascular
Applicant
Fukuda Denshi USA, Inc. 12539 130th Ln. Ne, Kirkland WA
Third party review
No

Clearances, product code DSF

Trailing 12 months

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

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