FDA product code · General and plastic surgery

Mountable Electromechanical Surgical System For Transluminal Approaches

Name: FDA decisions, review times, recalls and adverse event reports for product code QNM
Creator: 510(k) Report

QNMClass II21 CFR 878.4961510(k) required8 decisions since 20210 recalls

8 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 90 days (half between 43 and 96). No recall names this code. The most-cited predicate is DEN190022, named by 4 later devices.

A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.

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 QNM 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 · QNM

4in 2025

2007high 4 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QNM

64in 2025

2007high 64 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QNM

No recall names QNM since 2007.

Adverse event reports per year · QNM

1in 2022

2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code QNM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	0	—	1
2023	1	—	0
2024	2	—	0
2025	4	64	0
2026	0	—	—

FIG. 1 — QNM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QNM? 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

Mountable Electromechanical Surgical System For Transluminal Approaches

Which predicates do QNM devices cite most?

Which QNM devices have the deepest lineage?

What has FDA decided in QNM lately?