510(k) Report

FDA product code · Obstetrics and gynecology

Contraception Calculator

MPTClass II21 CFR 884.5350510(k) required1 decision since 19960 recalls

1 FDA decision since 1996. 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 MPT 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 · MPT

FDA has decided no MPT device since 2007.

Median 510(k) review, days · MPT

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

Recalls per year · MPT

No recall names MPT since 2007.

Adverse event reports per year · MPT

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

Planning a device in MPT? 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 MPT lately?

  • K954183Ovulation Calculator/Conception CalculatorHector Vides · 1996

The one MPT decision →

Related product codes

Other codes under 21 CFR 884.5350.

HDW Diaphragm, Contraceptive (And Accessories)