510(k) Report

FDA product code · General and plastic surgery

Mesh, Surgical, Collagen, Diaphragmatic Hernia

OWVClass II21 CFR 878.3300510(k) required1 decision since 20141 recall

1 FDA decision since 2014. 1 recall names this code; it is not Class I. The most-cited predicate is K133011, named by 1 later device.

For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.

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 OWV 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 · OWV

1in 2014

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

2026 to Oct 25, outlined.

Median 510(k) review, days · OWV

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

Recalls per year · OWV

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OWV

2in 2022

2016: 12022: 2
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code OWV, 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—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—02
20230—00
20240—10
20250—00
20260—0—
FIG. 1 — OWV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OWV? 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 OWV devices cite most?

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

  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20141cites it

Which OWV devices have the deepest lineage?

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

  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20148generations

What has FDA decided in OWV lately?

  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20141 recall

The one OWV decision →

What has been recalled in OWV lately?

  • K133011Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; andCook Biotech, Inc. · Nov 22, 2024Class II

Related product codes

Other codes under 21 CFR 878.3300.

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