# K050232: Rigiflex Single-Use Achalasia Balloon Dilator

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 11, 2005 after 38 days
- Product code: PID (Esophageal Dilator Balloon With Or Without Electrode Sensors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K781772: Catheter, Transluminal Balloon, Medi-Tech, Inc. (1979). Our OCR of the scanned summary read K781772, FDA’s number for Catheter, Transluminal Balloon (Medi-Tech, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Boston Scientific Rigiflex™ Achalasia Balloon Dilator”. Kept off the family tree. Summary page 4.

## Most influential descendants
- K182895: Wilson-Cook Achalasia Balloon (2019), 0 descendants of its own

## Recalls of this device
- May 28, 2013 · Class III · Z-1671-2013: Product labeled with incorrect expiration date.

## Indications for use
The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

Source page: https://510kreport.com/device/K050232
Methodology: https://510kreport.com/methodology