510(k) Report

FDA product code · Orthopedic

Tester, Stiffness, Cartilage, Arthroscopic

NGRClass II21 CFR 888.1100510(k) required2 decisions since 20010 recalls

2 FDA decisions since 2001. 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, orthopedic panel

Twenty years of NGR 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 · NGR

FDA has decided no NGR device since 2007.

Median 510(k) review, days · NGR

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

Recalls per year · NGR

No recall names NGR since 2007.

Adverse event reports per year · NGR

No MAUDE report names NGR since 2007.

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—00
20260—0—
FIG. 1 — NGR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NGR? 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 888.1100.