510(k) Report

FDA product code · Obstetrics and gynecology

Dilator, Cervical, Synthetic, Osmotic

PKNClass II21 CFR 884.4260510(k) required1 decision since 20150 recalls

1 FDA decision since 2015. No recall names this code. The most-cited predicate is K143447, named by 1 later device.

Cervical softening and dilation

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 PKN 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 · PKN

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PKN

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

Recalls per year · PKN

No recall names PKN since 2007.

Adverse event reports per year · PKN

3in 2025

2021: 22022: 22024: 52025: 3
2007high 5 (2024) · low 0 (2007)2025

MAUDE reports naming product code PKN, 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
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—02
20220—02
20230—00
20240—05
20250—03
20260—0—
FIG. 1 — PKN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PKN? 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

Which predicates do PKN devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K143447Dilapan-SMedicem Technology S.R.O · 20151cites it

Which PKN devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K143447Dilapan-SMedicem Technology S.R.O · 20151generation

What has FDA decided in PKN lately?

  • K143447Dilapan-SMedicem Technology S.R.O · 2015

The one PKN decision →

Related product codes

Other codes under 21 CFR 884.4260.

HDY Dilator, Cervical, Hygroscopic-LaminariaPFJ Catheter, Balloon, Dilation Of Cervical Canal…PON Catheter, Balloon, Dilation Of Cervical Canal