FDA product code · Obstetrics and gynecology

Monitor, Pressure, Arterial, Fetal, Ultrasonic

Name: FDA decisions, review times, recalls and adverse event reports for product code HEQ
Creator: 510(k) Report

HEQClass II21 CFR 884.2660510(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 HEQ 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.

FIG. 1 — HEQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HEQ? 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 884.2660.

HEP Monitor, Blood-Flow, Ultrasonic HEK Monitor, Heart Sound, Fetal, Ultrasonic MAA Monitor, Fetal Doppler Ultrasound HEJ Monitor, Hemic Sound, Ultrasonic HEL Monitor, Heart Rate, Fetal, Ultrasonic KNG Monitor, Ultrasonic, Fetal LXE Doppler, Fetal, Ultrasound HEI Monitor, Heart-Valve Movement, Fetal, Ultrasonic