510(k) Report

FDA product code · Obstetrics and gynecology

Heater, Perineal, Direct Contact

HGZClass II21 CFR 884.5390510(k) exempt1 decision since 19940 recalls

FDA lists HGZ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 884.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1994. 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, obstetrics and gynecology panel

Twenty years of HGZ 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 · HGZ

FDA has decided no HGZ device since 2007.

Median 510(k) review, days · HGZ

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

Recalls per year · HGZ

No recall names HGZ since 2007.

Adverse event reports per year · HGZ

No MAUDE report names HGZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
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 — HGZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HGZ? 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

What has FDA decided in HGZ lately?

  • K921885E1070 & E1080 Series Reusable Lletz ElectrodesValleylab, Inc. · 1994

The one HGZ decision →

Related product codes

Other codes under 21 CFR 884.5390.

HHA Heater, Perineal, Radiant, Non-ContactKND Heater, Perineal