510(k) Report

FDA product code · General and plastic surgery

Camera, Still, Surgical

FTTClass I21 CFR 878.4160510(k) exempt1 decision since 19820 recalls

FDA lists FTT 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. 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 and plastic surgery panel

Twenty years of FTT 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 · FTT

FDA has decided no FTT device since 2007.

Median 510(k) review, days · FTT

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

Recalls per year · FTT

No recall names FTT since 2007.

Adverse event reports per year · FTT

2in 2020

2007: 22016: 12017: 132018: 22019: 12020: 2
2007high 13 (2017) · low 0 (2008)2025

MAUDE reports naming product code FTT, 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—02
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—013
20180—02
20190—01
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — FTT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FTT? 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

What has FDA decided in FTT lately?

  • K823534Stereomed CameraDiseases of the Skin Clinic, P.A. · 1982

The one FTT decision →

Related product codes

Other codes under 21 CFR 878.4160.

KQM Camera, Surgical And AccessoriesFTS Camera, Cine, Endoscopic, With AudioFXR Holder, Camera, SurgicalFWH Camera, Cine, Surgical, Without AudioSFG Camera, Surgical, MeasurementFWK Camera, Cine, Microsurgical, With AudioFWF Camera, Television, Endoscopic, Without AudioFWD Camera, Television, Microsurgical, Without AudioFWB Camera, Television, Surgical, Without AudioFXS Frame, Camera, SurgicalFWG Camera, Television, Endoscopic, With AudioFWC Camera, Television, Surgical, With Audio