Cleared Traditional

K042742 - HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)

K042742 is an FDA 510(k) clearance for HEIDELBERG RETINA TOMOGRAPH II / ROSTOC..., manufactured by Heidelberg Engineering. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K042742 · Heidelberg Engineering · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
9d
Days
Class 2
Risk

K042742 is an FDA 510(k) clearance for the HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM). Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Heidelberg Engineering (Dossenheim, DE). The FDA issued a Cleared decision on October 13, 2004 after a review of 9 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042742

510(k) Number K042742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date October 13, 2004
Days to Decision 9 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
101d faster than avg
Panel avg: 110d · This submission: 9d
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

Tuv America, Inc.
STEFAN PREISS

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 K042742.
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
K052935 · Heidelberg Engineering · Jan 2006
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
K051940 · Sis Ltd., Surgical Instrument Systems · Sep 2005
PACHYCAM
K041841 · Oculus Optikgerate GmbH · Jan 2005
PATHFINDER
K031788 · Massie Research Laboratories, Inc. · Sep 2004
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
K040913 · Bausch & Lomb · Jul 2004
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
K030393 · Haag-Streit Holding AG · Sep 2003
K042742 · HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
Download PDF FDA Summary Heidelberg Engineering