Cleared Traditional

K991284 - ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM

K991284 is an FDA 510(k) clearance for ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM, manufactured by Nidek, Inc.. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K991284 · Nidek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
113d
Days
Class 2
Risk

K991284 is an FDA 510(k) clearance for the ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on August 6, 1999 after a review of 113 days - within the typical 510(k) review window.

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 Nidek, Inc. devices

FDA 510(k) Submission Details - K991284

510(k) Number K991284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1999
Decision Date August 06, 1999
Days to Decision 113 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 110d · This submission: 113d
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 18
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K991284.
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
K051940 · Sis Ltd., Surgical Instrument Systems · Sep 2005
PACHYCAM
K041841 · Oculus Optikgerate GmbH · Jan 2005
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K042742 · Heidelberg Engineering · Oct 2004
ORBSCAN
K984443 · Technolas Perfect Vision GmbH · Mar 1999