510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911246Substantially Equivalent

The Mediscus Pedcare Management System-Model 2

Medical Group, Buena Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911246 is the FDA 510(k) clearance record for THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2, a class II device, cleared for The Medical Group, Inc. on under FDA product code INX (Bed, Air Fluidized). FDA records list 16 510(k) clearances for The Medical Group, Inc., from to . As of , FDA records show no recalls naming K911246.

Clearance record

Decision date
Received
(77 days to decision)
Product code
INX Bed, Air Fluidized
Regulation
21 CFR 890.5160
Device class
Class II
Review panel
Physical Medicine
Applicant
The Medical Group, Inc. P.O. Box 5067, Buena Park CA
Third party review
No

Clearances, product code INX

Trailing 12 months

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

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