510(k) Report

FDA product code · General hospital

Topical Approximation System

MZRClass I21 CFR 880.5240510(k) exempt0 decisions0 recalls

FDA lists MZR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 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, general hospital panel

Twenty years of MZR 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 · MZR

FDA has decided no MZR device since 2007.

Median 510(k) review, days · MZR

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

Recalls per year · MZR

No recall names MZR since 2007.

Adverse event reports per year · MZR

3in 2022

2018: 12020: 842021: 12022: 3
2007high 84 (2020) · low 0 (2007)2025

MAUDE reports naming product code MZR, 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
20150—00
20160—00
20170—00
20180—01
20190—00
20200—084
20210—01
20220—03
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MZR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MZR? 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

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