FDA product code · Obstetrics and gynecology
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
2 FDA decisions since 2013. 1 recall names this code; it is not Class I. The most-cited predicate is K131206, named by 2 later devices.
Mechanical dilation of the cervical canal for labor.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PFJ 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 · PFJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PFJ
Too few PFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PFJ
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PFJ
7in 2025
MAUDE reports naming product code PFJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 3 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
Planning a device in PFJ? 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) ReportRelated product codes
Other codes under 21 CFR 884.4260.