510(k) · Cleared
ClearedUtah CVX-Ripe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Utah Medical Products, Inc. · PFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Cleared on Aug 28, 2015 as substantially equivalent to K131206 (Cook, Inc., 2013) after a 270-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Aug 28, 2015
- Review
- 270 days
- Class
- Class II
- Product code
- PFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021012 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021012 Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC · 2002
- 2 generations backK040625 Atad Ard CatheterAtad Developments, Ltd. · 2005
- 1 generation backK131206 Cook Cervical Ripening BalloonCook, Inc. · 2013
- This deviceK143424 Utah CVX-RipeUtah Medical Products, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002 | — |
| −2 | K040625 | Atad Ard Catheter | Atad Developments, Ltd. | 2005 | — |
| −1 | K131206 | Cook Cervical Ripening Balloon | Cook, Inc. | 2013 | — |
| 0 (this device) | K143424 | Utah CVX-Ripe | Utah Medical Products, Inc. | 2015 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PFJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131206 | Cook Cervical Ripening BalloonSummary page 4…balloon, dilation of cervical canal) Predicate Device The predicate device is the Cook® Cervical Ripening Balloon cleared September 27, 2013 under 510(k) number K131206. Device Description The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the c… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K131206.
How does its category compare?
All PFJ devicesPFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143424: Utah CVX-Ripe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143424
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026