510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011433Substantially Equivalent

Ballert Cranial Molding Helmet

Gema, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011433 is the FDA 510(k) clearance record for BALLERT CRANIAL MOLDING HELMET, a class II device, cleared for Gema, Inc. on under FDA product code MVA (Orthosis, Cranial). FDA records list one 510(k) clearance for Gema, Inc. As of , FDA records show no recalls naming K011433.

Clearance record

Decision date
Received
(33 days to decision)
Product code
MVA Orthosis, Cranial
Regulation
21 CFR 882.5970
Device class
Class II
Review panel
Neurology
Applicant
Gema, Inc. 2434 W. Peterson Ave., Chicago IL
510(k) summary
Statement
Third party review
No

Clearances, product code MVA

Trailing 12 months

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

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