# K143447: Dilapan-S

- Pathway: 510(k) (Traditional)
- Applicant: Medicem Technology S.R.O
- Decided: Apr 17, 2015 after 136 days
- Product code: PKN (Dilator, Cervical, Synthetic, Osmotic)
- Device class: 2
- Regulation: 21 CFR 884.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880196 (1988). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880196: Laminaria, Medgyn Products, Inc. (1988) Summary page 4.

## Most influential descendants
- K160664: Aqueduct 100 Cervical Dilator (2016), 3 descendants of its own
- K202433: Aqueduct 200 Cervical Dilation Balloon Catheter (2021), 0 descendants of its own
- K202427: Aqueduct 100 Plus Cervical Dilation Balloon Catheter (2020), 0 descendants of its own
- K190813: CrossBay Cervical Dilator Catheter System (2019), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K143447
Methodology: https://510kreport.com/methodology