510(k) · Cleared
Recalled · Class III · 2013Rigiflex Single-Use Achalasia Balloon Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · PID Esophageal Dilator Balloon With Or Without Electrode Sensors
Cleared on Mar 11, 2005 after a 38-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it. It has been recalled once.
- Decided
- Mar 11, 2005
- Review
- 38 days
- Class
- Class II
- Product code
- PID
- Recalls
- 1
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK050232 Rigiflex Single-Use Achalasia Balloon DilatorBoston Scientific Corp · 2005
- Descendant · cites it directly · 0 of its ownK182895 Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182895Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050232 | Rigiflex Single-Use Achalasia Balloon Dilator | Boston Scientific Corp | 2005 | — |
| +1 | K182895 | Wilson-Cook Achalasia Balloon | Wilson-Cook Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PID? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K781772 | FDA’s K781772 is Catheter, Transluminal Balloon 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…x™ II Single-Use Achalasia Balloon Dilator Balloon Dilatation Catheter Class I, per 21 CFR Part 876, Section 5365 Boston Scientific Rigiflex™ Achalasia Balloon Dilator (K781772). The Rigiflex™ ] Single-Use Achalasia Balloon Dilator consists of a balloon, catheter shaft, distal tip and proximal end. The… | 1979 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182895 | Wilson-Cook Achalasia Balloon | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2013 | Class III | Z-1671-2013 | Incorrect or no expiration date | Product labeled with incorrect expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K182895 (Wilson-Cook Medical, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PID devicesPID Esophageal Dilator Balloon With Or Without Electrode Sensors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PID
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PID
Too few PID 510(k)s in any year since 2007 to give a median.
Recalls per year · PID
No recall names PID since 2007.
Adverse event reports per year · PID
19in 2025
MAUDE reports naming product code PID, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 83 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050232: Rigiflex Single-Use Achalasia Balloon Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050232
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026