510(k) Report

FDA product code · General and plastic surgery

Tape, Camera, Surgical

FXNClass I21 CFR 878.4160510(k) exempt4 decisions since 19960 recalls

FDA lists FXN 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. 4 FDA decisions since 1996. No recall names this code. The most-cited predicate is K131596, named by 4 later devices.

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 FXN 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 · FXN

2in 2013

2007: 12013: 2
2007high 2 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FXN

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

Recalls per year · FXN

No recall names FXN since 2007.

Adverse event reports per year · FXN

No MAUDE report names FXN since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20132—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — FXN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FXN? 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

Which predicates do FXN devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K131596Wound Measuring & Monitoring DeviceWoundvision, LLC · 20134cite it
  • K070426Silhouette, Model 1000.01Aranz Medical Limited · 20071cites it

Which FXN devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K131596Wound Measuring & Monitoring DeviceWoundvision, LLC · 20131generation

What has FDA decided in FXN lately?

  • K131596Wound Measuring & Monitoring DeviceWoundvision, LLC · 2013
  • K130165Pictzar Digital Planimetry Software Application 7.0Advanced Planimetric Services, LLC · 2013
  • K070426Silhouette, Model 1000.01Aranz Medical Limited · 2007
  • K962148Verge VideometerVerg, Inc. · 1996

All 4 FXN decisions →

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