510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120065Substantially Equivalent

Plaxtron Suction Unit, Model 88Aa51/88aa61 Series

Plaxtron Industrial (M) Sdn. Bhd., Kaohsiung City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120065 is the FDA 510(k) clearance record for PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES, a class II device, cleared for Plaxtron Industrial (M) Sdn. Bhd. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list one 510(k) clearance for Plaxtron Industrial (M) Sdn. Bhd. As of , FDA records show 3 recalls naming K120065.

Clearance record

Decision date
Received
(85 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Plaxtron Industrial (M) Sdn. Bhd. # 15-2, Ln. 26, Mincyuan, Kaohsiung City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JCX

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