# K040625: Atad Ard Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Atad Developments, Ltd.
- Decided: Jan 18, 2005 after 315 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
Longest line of descent: 1 generation back to K021012 (2002). 1 ancestor in all.
6 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)
- K021012: Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM, Quality Medical Solusions, LLC (2002) Summary page 1.

## Most influential descendants
- 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
- K190813: CrossBay Cervical Dilator Catheter System (2019), 0 descendants of its own

## Indications for use
The Atad Pre-Induction Cervical Dilator is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

Source page: https://510kreport.com/device/K040625
Methodology: https://510kreport.com/methodology