510(k) Report

FDA product code · Gastroenterology and urology

Esophageal Dilator Balloon With Or Without Electrode Sensors

PIDClass II21 CFR 876.5980510(k) required3 decisions since 20050 recalls

3 FDA decisions since 2005. No recall names this code. The most-cited predicate is K050232, named by 1 later device.

To dilate the lower esophageal sphincter of patients with Achalasia.

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

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of PID at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — PID by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PID? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PID devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K050232Rigiflex Single-Use Achalasia Balloon DilatorBoston Scientific Corp · 20051cites it

Which PID devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K132337Esoflip Balloon Dilation CatheterCrospon, Ltd. · 20133generations
  • K182895Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc. · 20191generation

What has FDA decided in PID lately?

  • K182895Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc. · 2019
  • K132337Esoflip Balloon Dilation CatheterCrospon, Ltd. · 20131 recall
  • K050232Rigiflex Single-Use Achalasia Balloon DilatorBoston Scientific Corp · 20051 recall

All 3 PID decisions →

Related product codes

Other codes under 21 CFR 876.5980.

PSG Percutaneous Endoscopic Gastrostomy KitPIF Gastrointestinal Tubes With Enteral Specific…PSI Perineal Irrigation KitEYN Tray, Irrigation, SterilePSE Needle Catheter Jejunostomy KitFPD Tube, FeedingFHT Set, Gavage, Infant, SterileLCG Intestinal Splinting TubesNGU Balloon, Liver TamponadePRT Gastric Irrigation And Aspiration KitPSH Percutaneous Replacement Gastrostomy Tube KitPLI Gastrointestional Tube Holder