510(k) Report

FDA product code · Obstetrics and gynecology

Pelvimeter, Internal

LBXClass II21 CFR 884.4530510(k) required1 decision since 19830 recalls

1 FDA decision since 1983. 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 LBX 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 · LBX

FDA has decided no LBX device since 2007.

Median 510(k) review, days · LBX

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

Recalls per year · LBX

No recall names LBX since 2007.

Adverse event reports per year · LBX

3in 2022

2022: 3
2007high 3 (2022) · low 0 (2007)2025

MAUDE reports naming product code LBX, 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—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—03
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — LBX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LBX? 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.