# K880196: Laminaria

- Pathway: 510(k) (Traditional)
- Applicant: Medgyn Products, Inc.
- Decided: May 6, 1988 after 101 days
- Product code: HDY (Dilator, Cervical, Hygroscopic-Laminaria)
- 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
No predicates in its family tree.
5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K143447: Dilapan-S (2015), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K880196
Methodology: https://510kreport.com/methodology