510(k) Report

FDA product code · Obstetrics and gynecology

Craniotribe

HFZClass II21 CFR 884.4500510(k) required0 decisions0 recalls

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, obstetrics and gynecology panel

Twenty years of HFZ 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 · HFZ

FDA has decided no HFZ device since 2007.

Median 510(k) review, days · HFZ

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

Recalls per year · HFZ

No recall names HFZ since 2007.

Adverse event reports per year · HFZ

No MAUDE report names HFZ 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 — HFZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HFZ? 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 884.4500.

KNB Instrument, Destructive, Fetal, ObstetricHHN CleidoclastHDI Hook, Destructive, ObstetricalHGA Cranioclast