510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945062Substantially Equivalent

Vacplus

KCI USA, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945062 is the FDA 510(k) clearance record for VACPLUS, a class II device, cleared for Kinetic Concepts, Inc. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 76 510(k) clearances for KCI USA, INC., from to . As of , FDA records show no recalls naming K945062.

Clearance record

Decision date
Received
(151 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
Kinetic Concepts, Inc. P.O. Box 659508, San Antonio TX
510(k) summary
Statement
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