510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894922Substantially Equivalent

Wr3500 and Wr3600 Series Recorders

Western Graphtec, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894922 is the FDA 510(k) clearance record for WR3500 AND WR3600 SERIES RECORDERS, a class I device, cleared for Western Graphtec on under FDA product code DSF (Recorder, Paper Chart). FDA records list one 510(k) clearance for Western Graphtec. As of , FDA records show no recalls naming K894922.

Clearance record

Decision date
Received
(177 days to decision)
Product code
DSF Recorder, Paper Chart
Regulation
21 CFR 870.2810
Device class
Class I
Review panel
Cardiovascular
Applicant
Western Graphtec 11 Vanderbilt St., Irvine CA
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