510(k) Report

FDA product code · General hospital

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

OMFClass II21 CFR 880.5970510(k) required2 decisions since 20090 recalls

2 FDA decisions since 2009. No recall names this code. The most-cited predicate is K083121, named by 1 later device.

When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.

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 hospital panel

Twenty years of OMF 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 · OMF

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMF

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

Recalls per year · OMF

No recall names OMF since 2007.

Adverse event reports per year · OMF

1in 2017

2010: 12013: 62017: 1
2007high 6 (2013) · low 0 (2007)2025

MAUDE reports naming product code OMF, 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
20091—00
20101—01
20110—00
20120—00
20130—06
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OMF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OMF? 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 OMF devices cite most?

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

  • K083121Neo Mapcath Sensor StyletCorpak Medsystems · 20091cites it

Which OMF devices have the deepest lineage?

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

  • K093510Lumenvu Catheter Guidance SystemSonosite,Inc. · 20107generations

What has FDA decided in OMF lately?

  • K093510Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010
  • K083121Neo Mapcath Sensor StyletCorpak Medsystems · 2009

All 2 OMF decisions →

Related product codes

Other codes under 21 CFR 880.5970.

OKC Implanted Subcutaneous Securement CatheterPWR Catheter Repair KitLJS Catheter, Intravascular, Therapeutic…PZW Catheter Access Cover, Tamper-ResistantODY Tunneled Catheter Remover