510(k) · Cleared
ClearedLaminaria
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medgyn Products, Inc. · HDY Dilator, Cervical, Hygroscopic-Laminaria
Cleared on May 6, 1988 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 6, 1988
- Review
- 101 days
- Class
- Class II
- Product code
- HDY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK880196 LaminariaMedgyn Products, Inc. · 1988
- Descendant · cites it directly · 4 of its ownK143447 Dilapan-SMedicem Technology S.R.O · 2015
- 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
Most influential descendants
Showing 5 of 5 · See all- K143447Dilapan-SMedicem Technology S.R.O · 2015 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K880196 | Laminaria | Medgyn Products, Inc. | 1988 | — |
| +1 | K143447 | Dilapan-S | Medicem Technology S.R.O | 2015 | — |
| +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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143447 | Dilapan-S | 2015 | 4 |
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, K143447 (Medicem Technology S.R.O, 2015) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K880196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880196: Laminaria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880196
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026