510(k) · Cleared
ClearedAtad Ard Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atad Developments, Ltd. · HDY Dilator, Cervical, Hygroscopic-Laminaria
Cleared on Jan 18, 2005 as substantially equivalent to K021012 (Quality Medical Solusions, LLC, 2002) after a 315-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it.
- Decided
- Jan 18, 2005
- Review
- 315 days
- Class
- Class II
- Product code
- HDY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021012 (2002). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK021012 Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC · 2002
- This deviceK040625 Atad Ard CatheterAtad Developments, Ltd. · 2005
- Descendant · cites it directly · 5 of its ownK131206 Cook Cervical Ripening BalloonCook, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK160664 Aqueduct 100 Cervical DilatorGtimd, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK202433 Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK202427 Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK190813 CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131206Cook Cervical Ripening BalloonCook, Inc. · 2013 · cites it directly5descendants
- K160664Aqueduct 100 Cervical DilatorGtimd, LLC · 2016 · 2 generations on3descendants
- K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021 · 3 generations on0descendants
- K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020 · 3 generations on0descendants
- K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002 | — |
| 0 (this device) | K040625 | Atad Ard Catheter | Atad Developments, Ltd. | 2005 | — |
| +1 | K131206 | Cook Cervical Ripening Balloon | Cook, Inc. | 2013 | — |
| +2 | K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016 | — |
| +3 | K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | 2021 | — |
| +3 | K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | 2020 | — |
| +3 | K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 HDY? 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 |
|---|---|---|---|
| * | K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMSummary page 1…equivalence: The Atad Pre-induction Cervical Dilator (Atad Dilator) is substantially equivalent to the Quality Medical Solutions, LLC Laminaria Cervical Dilator, K021012, and other legally marketable laminaria indicated for cervical dilation. 4. Description of Device: The Atad Dilator is an 1… | 2002 |
| † | K890869 | Bard Hysterosalpingography Catheters | 1989 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131206 | Cook Cervical Ripening Balloon | 2013 | 5 |
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?
- Its one ancestor has no recall.
- Of its descendants, K131206 (Cook, Inc., 2013) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HDY devicesHDY Dilator, Cervical, Hygroscopic-Laminaria: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDY
FDA has decided no HDY device since 2007.
Median 510(k) review, days · HDY
Too few HDY 510(k)s in any year since 2007 to give a median.
Recalls per year · HDY
No recall names HDY since 2007.
Adverse event reports per year · HDY
3in 2022
MAUDE reports naming product code HDY, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Atad Pre-Induction Cervical Dilator 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/K040625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040625: Atad Ard Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040625
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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