# K021012: Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM

- Pathway: 510(k) (Traditional)
- Applicant: Quality Medical Solusions, LLC
- Decided: Jun 25, 2002 after 88 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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.

## Most influential descendants
- K040625: Atad Ard Catheter (2005), 6 descendants of its own
- K131206: Cook Cervical Ripening Balloon (2013), 5 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

## Indications for use
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

Source page: https://510kreport.com/device/K021012
Methodology: https://510kreport.com/methodology