510(k) Report

510(k) · Cleared

Cleared

Wilson-Cook Achalasia Balloon

K182895510(k) TraditionalCleared Jan 25, 2019102-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wilson-Cook Medical, Inc. · PID Esophageal Dilator Balloon With Or Without Electrode Sensors

Cleared on Jan 25, 2019 as substantially equivalent to K050232 (Boston Scientific Corp, 2005) after a 102-day review. Its family tree reaches back 1 generation to 2005.

Decided
Jan 25, 2019
Review
102 days
Class
Class II
Product code
PID
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K050232 (2005). No later device cites it as a predicate yet.

K050232 · Rigiflex Single-Use Achalasia Balloon Dilator · Boston Scientific Corp · 2005 · recalled2005201020152020
K050232 · Rigiflex Single-Use Achalasia Balloon Dilator · Boston Scientific Corp · 2005 · recalled0
  1. Root · 1 generation backK050232 Rigiflex Single-Use Achalasia Balloon DilatorBoston Scientific Corp · 2005 · Recalled
  2. This deviceK182895 Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K050232Rigiflex Single-Use Achalasia Balloon DilatorBoston Scientific Corp20051
0 (this device)K182895Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc.2019—
FIG. 1 — Lineage of K182895, 2005–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K050232Rigiflex Single-Use Achalasia Balloon Dilator
Summary page 4
…ss II Review Panel: Gastroenterology-Urology Predicate Device Name: Rigiflex II Single Use Achalasia Balloon Dilator 510(k) Number: K050232 Date: 03/11/2005 Intended Use The device is used to dilate the lower esophageal sphincter in patients with Ach…
Boston Scientific Corp20051

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.

How does its category compare?

All PID devices

PID Esophageal Dilator Balloon With Or Without Electrode Sensors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PID

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

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

2019: 22020: 42021: 102022: 92023: 102024: 832025: 19
2007high 83 (2024) · low 0 (2007)2025

MAUDE reports naming product code PID, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—02
20200—04
20210—010
20220—09
20230—010
20240—083
20250—019
20260—0—

What is it indicated for?

The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.

Indications for use as stated in the FDA summary.

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

Recent decisions in PID

The PID category page

  • K132337Esoflip Balloon Dilation CatheterCrospon, Ltd. · 20131 recall
  • K050232Rigiflex Single-Use Achalasia Balloon DilatorBoston Scientific Corp · 20051 recall

https://510kreport.com/device/K182895 · printed Nov 4, 2026

Cite this page

510(k) Report. “K182895: Wilson-Cook Achalasia Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182895

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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