510(k) Report

FDA product code · General hospital

Sharps Needle Destruction Device

MTVClass II21 CFR 880.6210510(k) required9 decisions since 19971 recall

9 FDA decisions since 1997. 510(k) reviews decided 2021–2025 took a median of 241 days (half between 241 and 241). 1 recall names this code; it is not Class I. The most-cited predicate is P120018, named by 1 later device.

A prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.

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, general hospital panel

Twenty years of MTV 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 · MTV

1in 2021

2016: 12018: 12021: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MTV

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

Recalls per year · MTV

No recall names MTV since 2007.

Adverse event reports per year · MTV

No MAUDE report names MTV since 2007.

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
20150—00
20161—00
20170—00
20181—00
20190—00
20200—00
20211—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MTV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MTV? 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