510(k) · Cleared
ClearedCook Cervical Ripening Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · PFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Cleared on Sep 27, 2013 as substantially equivalent to K040625 (Atad Developments, Ltd., 2005) after a 151-day review. Its family tree reaches back 2 generations to 2002. 5 later devices descend from it.
- Decided
- Sep 27, 2013
- Review
- 151 days
- Class
- Class II
- Product code
- PFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021012 (2002). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK021012 Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC · 2002
- 1 generation backK040625 Atad Ard CatheterAtad Developments, Ltd. · 2005
- This deviceK131206 Cook Cervical Ripening BalloonCook, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK160664 Aqueduct 100 Cervical DilatorGtimd, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK202433 Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK202427 Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK190813 CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019
- Descendant · cites it directly · 0 of its ownK143424 Utah CVX-RipeUtah Medical Products, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K160664Aqueduct 100 Cervical DilatorGtimd, LLC · 2016 · cites it directly3descendants
- K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021 · 2 generations on0descendants
- K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020 · 2 generations on0descendants
- K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019 · 2 generations on0descendants
- K143424Utah CVX-RipeUtah Medical Products, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002 | — |
| −1 | K040625 | Atad Ard Catheter | Atad Developments, Ltd. | 2005 | — |
| 0 (this device) | K131206 | Cook Cervical Ripening Balloon | Cook, Inc. | 2013 | — |
| +1 | K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016 | — |
| +2 | K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | 2021 | — |
| +2 | K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | 2020 | — |
| +2 | K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | 2019 | — |
| +1 | K143424 | Utah CVX-Ripe | Utah Medical Products, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
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 |
|---|---|---|---|
| * | K040625 | Atad Ard CatheterSummary page 1…alloon is substantially equivalent to the Atad Ike-Induction Cervical Dilator (Atad Developments and Medical Services Ltd.) cleared January 18, 2005 uinder 510(k) number K040625. K131206… | 2005 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K160664 (Gtimd, LLC, 2016) has gone furthest, with 3 descendants of its own.
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. 2013, 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 Cook Cervical Ripening Balloon is indicated for mechanical dilation of the cervical
canal prior to labor induction at term when the cervix is unfavorable for induction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131206 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131206: Cook Cervical Ripening Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131206
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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