510(k) Report

FDA product code · Ear, nose and throat

Implant, Hearing, Active, Middle Ear, Partially Implanted

MPVClass IIIPMA required2 decisions since 20000 recalls

2 FDA decisions since 2000. No recall names this code.

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, ear, nose and throat panel

Twenty years of MPV 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 · MPV

1in 2022

2007: 22008: 22009: 22010: 42011: 32012: 12013: 22014: 12015: 12016: 22020: 12022: 1
2007high 4 (2010) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPV

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

Recalls per year · MPV

No recall names MPV since 2007.

Adverse event reports per year · MPV

89in 2025

2007: 82008: 342009: 642010: 572011: 872012: 842013: 1292014: 1122015: 802016: 652017: 442018: 532019: 412020: 542021: 682022: 522023: 682024: 802025: 89
2007high 129 (2013) · low 8 (2007)2025

MAUDE reports naming product code MPV, 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
20072—08
20082—034
20092—064
20104—057
20113—087
20121—084
20132—0129
20141—0112
20151—080
20162—065
20170—044
20180—053
20190—041
20201—054
20210—068
20221—052
20230—068
20240—080
20250—089
20260—0—
FIG. 1 — MPV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MPV? 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