510(k) Report

FDA product code · General and plastic surgery

Prosthesis, Nail

MQZClass U4 decisions since 19850 recalls

4 FDA decisions since 1985. 510(k) reviews decided 2021–2025 took a median of 300 days (half between 300 and 300). No recall names this code. The most-cited predicate is K960843, named by 1 later device.

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 and plastic surgery panel

Twenty years of MQZ 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 · MQZ

1in 2024

2018: 12024: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQZ

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

Recalls per year · MQZ

No recall names MQZ since 2007.

Adverse event reports per year · MQZ

No MAUDE report names MQZ 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
20160—00
20170—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—
FIG. 1 — MQZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MQZ? 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