HEFClass I

Binder, Breast

21 CFR 880.5160 / General Hospital

HEF is the FDA product code for Binder, Breast, a class I device type, regulated under 21 CFR 880.5160. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: HEF
Device name: Binder, Breast
Regulation: 21 CFR 880.5160
Device class: Class I
Review panel: General Hospital
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: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order

Recent clearances

Product code HEF

FDA records hold no clearances under product code HEF.

Recent recalls

Product code HEF

FDA records show no recalls under product code HEF.

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)