FDA product code · Gastroenterology and urology

Vibrator For Climax Control Of Premature Ejaculation

Name: FDA decisions, review times, recalls and adverse event reports for product code PIA
Creator: 510(k) Report

PIAClass II21 CFR 876.5025510(k) exempt1 decision0 recalls

FDA lists PIA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision. No recall names this code.

Vibrator for climax control training for the treatment of premature ejaculation.

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 PIA 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.

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

Planning a device in PIA? 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