510(k) · Cleared
ClearedAqueduct 100 Cervical Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gtimd, LLC · PON Catheter, Balloon, Dilation Of Cervical Canal
Cleared on Aug 1, 2016 as substantially equivalent to K143447 (Medicem Technology S.R.O, 2015) and 1 other predicate after a 145-day review. Its family tree reaches back 3 generations to 2002. 3 later devices descend from it.
- Decided
- Aug 1, 2016
- Review
- 145 days
- Class
- Class II
- Product code
- PON
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K021012 (2002). 5 ancestors in all, the oldest K880196 (1988). 3 later devices descend from it, 3 citing it directly.
- 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 deviceK160664 Aqueduct 100 Cervical DilatorGtimd, LLC · 2016
- Descendant · cites it directly · 0 of its ownK202433 Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021
- Descendant · cites it directly · 0 of its ownK202427 Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020
- Descendant · cites it directly · 0 of its ownK190813 CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019
Most influential descendants
Showing 3 of 3 · See all- K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021 · cites it directly0descendants
- K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020 · cites it directly0descendants
- K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019 · cites it directly0descendants
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) | K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016 | — |
| +1 | K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | 2021 | — |
| +1 | K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K143447 | Dilapan-SSummary page 4…884.4260) Regulatory Class: II Product Code: PON III. Predicate Devices Primary Predicate Device: Dilapan-S (K143447) manufactured by Medicem Technology s.r.o. Reference Device: Cook Cervical Ripening Balloon (K131206) manufactured… | 2015 |
| * | K131206 | Cook Cervical Ripening BalloonSummary page 4…s Primary Predicate Device: Dilapan-S (K143447) manufactured by Medicem Technology s.r.o. Reference Device: Cook Cervical Ripening Balloon (K131206) manufactured by Cook, Inc. These predicate devices have not been subject to a design-related recall.… | 2013 |
What descends from it? (3)
3 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 14 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K202433 (Gtimd, LLC, 2021) has gone furthest, with 0 descendants of its own.
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. 2016, 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 Aqueduct 100 Cervical Dilation Balloon Catheter is intended to be used
whenever cervical softening and dilation is desired. Some examples are:
treatment of cervical stenosis, IUD placement and removal, Radium placement,
drainage of uterine cavity, endometrial biopsy, uterine curettage, suction
cannula aspiration, operative hysteroscopy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160664: Aqueduct 100 Cervical Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160664
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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