FDA product code · General and plastic surgery

Camera, Still, Endoscopic

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

FXMClass I21 CFR 878.4160510(k) exempt1 decision since 19825 recalls

FDA lists FXM as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1982. 5 recalls name this code, 0 of them Class I.

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 FXM 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 · FXM

FDA has decided no FXM device since 2007.

Median 510(k) review, days · FXM

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

Recalls per year · FXM

No recall names FXM since 2007.

Adverse event reports per year · FXM

1in 2020

2007high 5 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	3
2010	—	2
2011	—	5
2012	—	1
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	1
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in FXM? 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 878.4160.

KQM Camera, Surgical And Accessories FTS Camera, Cine, Endoscopic, With Audio FXR Holder, Camera, Surgical FWH Camera, Cine, Surgical, Without Audio SFG Camera, Surgical, Measurement FWK Camera, Cine, Microsurgical, With Audio FWF Camera, Television, Endoscopic, Without Audio FWD Camera, Television, Microsurgical, Without Audio FWB Camera, Television, Surgical, Without Audio FXS Frame, Camera, Surgical FWG Camera, Television, Endoscopic, With Audio FWC Camera, Television, Surgical, With Audio

Camera, Still, Endoscopic

What has FDA decided in FXM lately?

What has been recalled in FXM lately?

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