Cleared Traditional

K040913 - NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

K040913 is an FDA 510(k) clearance for NGDI (NEXT GENERATION DIAGNOSTIC INSTRU..., manufactured by Bausch & Lomb. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K040913 · Bausch & Lomb · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
106d
Days
Class 2
Risk

K040913 is an FDA 510(k) clearance for the NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT). Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Bausch & Lomb (San Dimas, US). The FDA issued a Cleared decision on July 23, 2004 after a review of 106 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.

FDA 510(k) Submission Details - K040913

510(k) Number K040913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date July 23, 2004
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DERWYN REUBER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MXK Device, Analysis, Anterior Segment

All 22
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K040913.
PACHYCAM
K041841 · Oculus Optikgerate GmbH · Jan 2005
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K042742 · Heidelberg Engineering · Oct 2004
PATHFINDER
K031788 · Massie Research Laboratories, Inc. · Sep 2004
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
K030393 · Haag-Streit Holding AG · Sep 2003
PENTACAM SCHEIMPFLUG CAMERA
K030719 · Oculus Optikgerate GmbH · Sep 2003
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · Nidek, Inc. · Aug 1999
K040913 · NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
Download PDF FDA Summary Bausch & Lomb