510(k) Report

FDA product code · Gastroenterology and urology

Neuromodulator For Obesity

PIMClass IIIPMA required1 decision since 20150 recalls

1 FDA decision since 2015. No recall names this code.

Weight reduction by peripheral neuromodulation.

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 PIM 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 · PIM

3in 2019

2015: 72016: 62017: 22018: 22019: 3
2007high 7 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PIM

Too few PIM 510(k)s in any year since 2007 to give a median.

Recalls per year · PIM

No recall names PIM since 2007.

Adverse event reports per year · PIM

2in 2020

2015: 52016: 172017: 262018: 112019: 62020: 2
2007high 26 (2017) · low 0 (2007)2025

MAUDE reports naming product code PIM, 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
20130—00
20140—00
20157—05
20166—017
20172—026
20182—011
20193—06
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PIM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PIM? 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