510(k) · Cleared
ClearedDilapan-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicem Technology S.R.O · PKN Dilator, Cervical, Synthetic, Osmotic
Cleared on Apr 17, 2015 as substantially equivalent to K880196 (Medgyn Products, Inc., 1988) after a 136-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Apr 17, 2015
- Review
- 136 days
- Class
- Class II
- Product code
- PKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880196 (1988). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK880196 LaminariaMedgyn Products, Inc. · 1988
- This deviceK143447 Dilapan-SMedicem Technology S.R.O · 2015
- Descendant · cites it directly · 3 of its ownK160664 Aqueduct 100 Cervical DilatorGtimd, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK202433 Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK202427 Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK190813 CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019
Most influential descendants
Showing 4 of 4 · See all- K160664Aqueduct 100 Cervical DilatorGtimd, LLC · 2016 · cites it directly3descendants
- K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021 · 2 generations on0descendants
- K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020 · 2 generations on0descendants
- K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880196 | Laminaria | Medgyn Products, Inc. | 1988 | — |
| 0 (this device) | K143447 | Dilapan-S | Medicem Technology S.R.O | 2015 | — |
| +1 | K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016 | — |
| +2 | K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | 2021 | — |
| +2 | K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | 2020 | — |
| +2 | K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PKN? 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 |
|---|---|---|---|
| * | K880196 | LaminariaSummary page 4…Product Code PKN 3. Legally marketed device claiming substantial equivalence to MedGyn Laminaria K880196 4. Description of Device: DILAPAN-S is a hygroscopic cervical dilator that is manufactured from AQUACRYL, a proprietary hydrogel… | 1988 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160664 | Aqueduct 100 Cervical Dilator | 2016 | 3 |
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, K160664 (Gtimd, LLC, 2016) has gone furthest, with 3 descendants of its own.
How does its category compare?
All PKN devicesPKN Dilator, Cervical, Synthetic, Osmotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PKN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PKN
Too few PKN 510(k)s in any year since 2007 to give a median.
Recalls per year · PKN
No recall names PKN since 2007.
Adverse event reports per year · PKN
3in 2025
MAUDE reports naming product code PKN, 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Dilapan-S is to be used whenever cervical softening and dilation is desired. Some examples are:
1. Cervical stenosis
a. related to dysmenorrhea
b. considered a possible cause of infertility
c. resulting from cauterization or conization
2. Placement and removal of intrauterine devices
3. Induction of labor
4. Radium placement
5. Drainage of uterine cavity
6. Endometrial biopsy
7. Uterine curettage
8. Suction cannula aspiration
9. Operative hysteroscopy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143447: Dilapan-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143447
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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