510(k) Report

FDA product code · General and plastic surgery

Mesh, Surgical, Collagen, Large Abdominal Wall Defects

OXKClass II21 CFR 878.3300510(k) required2 decisions since 20120 recalls

2 FDA decisions since 2012. No recall names this code. The most-cited predicate is K121289, named by 1 later device.

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 OXK 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 · OXK

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXK

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

Recalls per year · OXK

No recall names OXK since 2007.

Adverse event reports per year · OXK

2in 2024

2015: 22016: 62018: 72022: 22024: 2
2007high 7 (2018) · low 0 (2007)2025

MAUDE reports naming product code OXK, 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
20121—00
20131—00
20140—00
20150—02
20160—06
20170—00
20180—07
20190—00
20200—00
20210—00
20220—02
20230—00
20240—02
20250—00
20260—0—
FIG. 1 — OXK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OXK? 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 OXK devices cite most?

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

  • K121289LTM-Labaroscopic Surgical MeshLifecell Corp. · 20121cites it

Which OXK devices have the deepest lineage?

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

  • K130817LTN - Laparoscopic Surgical MeshLifecell Corp. · 20137generations
  • K121289LTM-Labaroscopic Surgical MeshLifecell Corp. · 20126generations

What has FDA decided in OXK lately?

  • K130817LTN - Laparoscopic Surgical MeshLifecell Corp. · 2013
  • K121289LTM-Labaroscopic Surgical MeshLifecell Corp. · 2012

All 2 OXK decisions →

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Other codes under 21 CFR 878.3300.

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