510(k) Report

FDA product code · Obstetrics and gynecology

Elevator, Uterine

HDPClass II21 CFR 884.4530510(k) required4 decisions since 19820 recalls

4 FDA decisions since 1982. 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 HDP 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 · HDP

FDA has decided no HDP device since 2007.

Median 510(k) review, days · HDP

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

Recalls per year · HDP

No recall names HDP since 2007.

Adverse event reports per year · HDP

1in 2020

2011: 12012: 12020: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code HDP, 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—00
20110—01
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HDP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HDP? 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 884.4530.