# K182159: Strome-Blitzer Cytology Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Adn International, LLC
- Decided: Jun 13, 2019 after 308 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- 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 K911588 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911588: Brandt Esophageal Cytology Balloon, Wilson-Cook Medical, Inc. (1992) Summary page 4.

## Indications for use
The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.

Source page: https://510kreport.com/device/K182159
Methodology: https://510kreport.com/methodology