510(k) Report

FDA product code · General and plastic surgery

Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

OXJClass II21 CFR 878.3300510(k) required2 decisions since 20140 recalls

2 FDA decisions since 2014. No recall names this code. The most-cited predicate is K130852, named by 2 later devices.

For reinforcement of soft tissue where weakness exists in abdominal wall defects.

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 OXJ 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 · OXJ

1in 2016

2014: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXJ

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

Recalls per year · OXJ

No recall names OXJ since 2007.

Adverse event reports per year · OXJ

1in 2017

2014: 22015: 72016: 12017: 1
2007high 7 (2015) · low 0 (2007)2025

MAUDE reports naming product code OXJ, 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
20141—02
20150—07
20161—01
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OXJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OXJ? 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 878.3300.