510(k) Report

FDA product code · General and plastic surgery

Mesh, Surgical, Deployment Balloon

OQLClass II21 CFR 878.3300510(k) required1 decision since 20100 recalls

1 FDA decision since 2010. No recall names this code. The most-cited predicate is K092726, named by 1 later device.

The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.

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 OQL 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 · OQL

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OQL

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

Recalls per year · OQL

No recall names OQL since 2007.

Adverse event reports per year · OQL

1in 2022

2016: 12018: 22022: 1
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code OQL, 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
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—02
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OQL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OQL? 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 OQL devices cite most?

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

  • K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 20101cites it

Which OQL devices have the deepest lineage?

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

  • K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 20104generations

What has FDA decided in OQL lately?

  • K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010

The one OQL decision →

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Other codes under 21 CFR 878.3300.

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