510(k) Report

FDA product code · General hospital

Binder, Breast

HEFClass I21 CFR 880.5160510(k) exempt0 decisions0 recalls

FDA lists HEF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of HEF at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · HEF

FDA has decided no HEF device since 2007.

Median 510(k) review, days · HEF

Too few HEF 510(k)s in any year since 2007 to give a median.

Recalls per year · HEF

No recall names HEF since 2007.

Adverse event reports per year · HEF

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code HEF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HEF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HEF? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 880.5160.

FQK Binder, PerinealKMO Binder, ElasticFSD Binder, AbdominalMDR Binder, Medical, Therapeutic