NDAClass I

Helmet, Cranial, For Protective Use

21 CFR 890.3025 / Physical Medicine

NDA is the FDA product code for Helmet, Cranial, For Protective Use, a class I device type, regulated under 21 CFR 890.3025. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: NDA
Device name: Helmet, Cranial, For Protective Use
Regulation: 21 CFR 890.3025
Device class: Class I
Review panel: Physical Medicine
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order

Recent clearances

Product code NDA

FDA records hold no clearances under product code NDA.

Recent recalls

Product code NDA

Z-2227-2009Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the...Biomet 3i, LLC / initiated 2006-12-11 / 24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)