FDA product code · Obstetrics and gynecology

Catheter, Balloon, Transcervical

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

MKNClass IIIPMA required0 decisions since 20030 recalls

0 FDA decisions since 2003. 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 MKN 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 · MKN

FDA has decided no MKN device since 2007.

Median 510(k) review, days · MKN

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

Recalls per year · MKN

No recall names MKN since 2007.

Adverse event reports per year · MKN

1in 2016

2007high 96 (2007) · low 0 (2017)2025

MAUDE reports naming product code MKN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	96
2008	—	84
2009	—	78
2010	—	82
2011	—	24
2012	—	8
2013	—	9
2014	—	7
2015	—	5
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in MKN? 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