Cleared Traditional

K030719 - PENTACAM SCHEIMPFLUG CAMERA

K030719 is an FDA 510(k) clearance for PENTACAM SCHEIMPFLUG CAMERA, manufactured by Oculus Optikgerate GmbH. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K030719 · Oculus Optikgerate GmbH · Ophthalmic device
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Sep 2003
Decision
193d
Days
Class 2
Risk

K030719 is an FDA 510(k) clearance for the PENTACAM SCHEIMPFLUG CAMERA. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Oculus Optikgerate GmbH (Woodinville, US). The FDA issued a Cleared decision on September 16, 2003 after a review of 193 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Oculus Optikgerate GmbH devices

FDA 510(k) Submission Details - K030719

510(k) Number K030719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2003
Decision Date September 16, 2003
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 110d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXK Device Classification - Class 2, Special Controls

Product Code MXK Device, Analysis, Anterior Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MXK Device, Analysis, Anterior Segment

All 15
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K030719.
ARGOS
K150754 · Santec Corporation · Oct 2015
PACHYCAM
K041841 · Oculus Optikgerate GmbH · Jan 2005
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K042742 · Heidelberg Engineering · Oct 2004
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · Nidek, Inc. · Aug 1999
ORBSCAN
K984443 · Technolas Perfect Vision GmbH · Mar 1999