510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821160Substantially Equivalent

Pneumo Drain T.m. Recorder #Pd-800

Sugen Industries, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821160 is the FDA 510(k) clearance record for PNEUMO DRAIN T.M. RECORDER #PD-800, a class II device, cleared for Sugen Industries, Inc. on under FDA product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered). FDA records list one 510(k) clearance for Sugen Industries, Inc. As of , FDA records show no recalls naming K821160.

Clearance record

Decision date
Received
(35 days to decision)
Product code
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Sugen Industries, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GCX

Trailing 12 months

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

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