510(k) Report

FDA product code · General and plastic surgery

Software Controlled Endoscope And Instrument Holder

QZBClass II21 CFR 876.1500510(k) required4 decisions since 20240 recalls

4 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 220 days (half between 154 and 267). No recall names this code. The most-cited predicate is K242323, named by 1 later device.

To hold and position endoscopes and instruments.

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 QZB 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 · QZB

2in 2025

2024: 12025: 22026 (partial year): 1
2007high 2 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QZB

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

Recalls per year · QZB

No recall names QZB since 2007.

Adverse event reports per year · QZB

No MAUDE report names QZB 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
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—00
20252—00
20261—0—
FIG. 1 — QZB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QZB? 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

Related product codes

Other codes under 21 CFR 876.1500.