510(k) Report

FDA product code · Orthopedic

Electronic Depth Gauge

OOLClass II21 CFR 888.3030510(k) required1 decision since 20090 recalls

1 FDA decision since 2009. No recall names this code.

For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures.

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, orthopedic panel

Twenty years of OOL 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 · OOL

1in 2009

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

2026 to Oct 25, outlined.

Median 510(k) review, days · OOL

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

Recalls per year · OOL

No recall names OOL since 2007.

Adverse event reports per year · OOL

No MAUDE report names OOL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OOL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OOL? 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 OOL devices have the deepest lineage?

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

  • K091992Eidosmed, Model EDG4.0Eidosmed, LLC · 20091generation

What has FDA decided in OOL lately?

  • K091992Eidosmed, Model EDG4.0Eidosmed, LLC · 2009

The one OOL decision →

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