510(k) · Cleared
Recalled · Class II · 2024Esoflip Balloon Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crospon, Ltd. · PID Esophageal Dilator Balloon With Or Without Electrode Sensors
Cleared on Oct 7, 2013 as substantially equivalent to K900924 (Wilson-Cook Medical, Inc., 1990) and 1 other predicate after a 73-day review. Its family tree reaches back 3 generations to 1999. It has been recalled once.
- Decided
- Oct 7, 2013
- Review
- 73 days
- Class
- Class II
- Product code
- PID
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991288 (1999). 5 ancestors in all, the oldest K900924 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991288 | Distender Series II Barostat | G & J Electronics, Inc. | 1999 | — |
| −2 | K092850 | Endoflip | Crospon, Ltd. | 2009 | — |
| −1 | K120997 | Barostat Software Option | Crospon, Ltd. | 2012 | — |
| 0 (this device) | K132337 | Esoflip Balloon Dilation Catheter | Crospon, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2002 | 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900924 | Wilson-Cook Balloon Dilation CathetersSummary page 4…atheter ES-330 Common/Usual Name: Esophageal Dilator’ Classification / CFR: KNQ/CFR 876.5365 / Class 2 Device: . ‘ EsoFLIP® Balloon Dilation Catheter _Predicate Devices: K 900924 - Cook Cndoscopy Achalasia Balloon K 120997 — Crospon — EndoF LIP® Catheter Device Description: The EsoFLIP® balloon dilation… | 1990 |
| * | K120997 | Barostat Software OptionSummary page 4…Dilator’ Classification / CFR: KNQ/CFR 876.5365 / Class 2 Device: . ‘ EsoFLIP® Balloon Dilation Catheter _Predicate Devices: K 900924 - Cook Cndoscopy Achalasia Balloon K 120997 — Crospon — EndoF LIP® Catheter Device Description: The EsoFLIP® balloon dilation catheter is a modification of the predicate C… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2024 | Class II | Z-2038-2024 | Nonconforming Material/Component | Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2013, this device’s year, is highlighted.
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 EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient 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/K132337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132337: Esoflip Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132337
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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