510(k) · Cleared
ClearedCrossBay Cervical Dilator Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossbay Medical · PON Catheter, Balloon, Dilation Of Cervical Canal
Cleared on Aug 23, 2019 as substantially equivalent to K160664 (Gtimd, LLC, 2016) after a 147-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Aug 23, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- PON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021012 (2002). 6 ancestors in all, the oldest K880196 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK021012 Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC · 2002
- 3 generations backK040625 Atad Ard CatheterAtad Developments, Ltd. · 2005
- 2 generations backK131206 Cook Cervical Ripening BalloonCook, Inc. · 2013
- 1 generation backK160664 Aqueduct 100 Cervical DilatorGtimd, LLC · 2016
- This deviceK190813 CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002 | — |
| −3 | K040625 | Atad Ard Catheter | Atad Developments, Ltd. | 2005 | — |
| −2 | K131206 | Cook Cervical Ripening Balloon | Cook, Inc. | 2013 | — |
| −1 | K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016 | — |
| 0 (this device) | K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2015 | 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 PON? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PON device
- #1 K202433 Aqueduct 200 Cervical Dilation Balloon Catheterscore 3.1 · 4 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K160664 | Aqueduct 100 Cervical DilatorSummary page 4…PON (catheter, balloon, dilation of cervical canal) III. PREDICATE DEVICE INFORMATION The predicate device is the Aqueduct 100 Cervical Dilation Balloon Catheter (K160664) The predicate device has not been subject to a design‐related recall. IV. DEVICE DESCRIPTION The CrossBay Cervical Dilator… | 2016 |
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 17 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K160664.
How does its category compare?
All PON devicesPON Catheter, Balloon, Dilation Of Cervical Canal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PON
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PON
Too few PON 510(k)s in any year since 2007 to give a median.
Recalls per year · PON
No recall names PON since 2007.
Adverse event reports per year · PON
3in 2021
MAUDE reports naming product code PON, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CrossBay™ Cervical Dilator Catheter System is intended to be used whenever cervical softening and dilation is desired. Some examples are:
• Treatment of cervical stenosis
• IUD placement and removal
• Placement of instruments for intrauterine radiotherapy
• Endometrial biopsy
• Global endometrial ablation
• Uterine tissue removal
• Uterine curettage
• Diagnostic hysteroscopy
• Operative hysteroscopy
This device is not intended for use in the induction of labor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190813: CrossBay Cervical Dilator Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190813
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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