510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003630Substantially Equivalent

Danmar Products Michigan Cranial Helmet

Danmar Products, Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003630 is the FDA 510(k) clearance record for DANMAR PRODUCTS MICHIGAN CRANIAL HELMET, a class II device, cleared for Danmar Products, Inc. on under FDA product code MVA (Orthosis, Cranial). FDA records list 3 510(k) clearances for Danmar Products, Inc., from to . As of , FDA records show no recalls naming K003630.

Clearance record

Decision date
Received
(186 days to decision)
Product code
MVA Orthosis, Cranial
Regulation
21 CFR 882.5970
Device class
Class II
Review panel
Neurology
Applicant
Danmar Products, Inc. 221 Jackson Industrial Dr., Ann Arbor MI
510(k) summary
Summary
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