510(k) Report

FDA product code · General and plastic surgery

Board, Arm (With Cover), Non-Sterile

NODClass I21 CFR 878.3910510(k) exempt0 decisions0 recalls

FDA lists NOD 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. 0 FDA decisions. 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 NOD 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 · NOD

FDA has decided no NOD device since 2007.

Median 510(k) review, days · NOD

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

Recalls per year · NOD

No recall names NOD since 2007.

Adverse event reports per year · NOD

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code NOD, 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—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
20240—00
20250—01
20260—0—
FIG. 1 — NOD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NOD? 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 878.3910.