510(k) · Cleared
ClearedLaminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Medical Solusions, LLC · HDY Dilator, Cervical, Hygroscopic-Laminaria
Cleared on Jun 25, 2002 after an 88-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 7 later devices descend from it.
- Decided
- Jun 25, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- HDY
- Recalls
- None
- Predicates
- 1
7 later devices descend from it, 1 citing it directly.
- This deviceK021012 Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC · 2002
- Descendant · cites it directly · 6 of its ownK040625 Atad Ard CatheterAtad Developments, Ltd. · 2005
- Descendant · 2 generations on · 5 of its ownK131206 Cook Cervical Ripening BalloonCook, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK160664 Aqueduct 100 Cervical DilatorGtimd, LLC · 2016
- Descendant · 4 generations on · 0 of its ownK202433 Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021
- Descendant · 4 generations on · 0 of its ownK202427 Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040625Atad Ard CatheterAtad Developments, Ltd. · 2005 · cites it directly6descendants
- K131206Cook Cervical Ripening BalloonCook, Inc. · 2013 · 2 generations on5descendants
- K160664Aqueduct 100 Cervical DilatorGtimd, LLC · 2016 · 3 generations on3descendants
- K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021 · 4 generations on0descendants
- K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002 | — |
| +1 | K040625 | Atad Ard Catheter | Atad Developments, Ltd. | 2005 | — |
| +2 | K131206 | Cook Cervical Ripening Balloon | Cook, Inc. | 2013 | — |
| +3 | K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016 | — |
| +4 | K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | 2021 | — |
| +4 | K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K951330 | Staol Laminaria Tents Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…ial distribution. Also, Equivalency overview chart path is attached. P' FDA file reference number 510k951330 Attachments inside notification VERY IMPORTANT: REFER TO TABLE omparison resu Standards… |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040625 | Atad Ard Catheter | 2005 | 6 |
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?
- Of its descendants, K040625 (Atad Developments, Ltd., 2005) has gone furthest, with 6 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?
Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021012: Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021012
Report an extraction error
Are you the manufacturer?
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