Cleared Traditional

K842892 - NIDEK DIGITAL KERATOMETER (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K842892 · Nidek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
74d
Days
Class 3
Risk

K842892 is an FDA 510(k) clearance for the NIDEK DIGITAL KERATOMETER. Classified as Intraocular Lens (product code HQL), Class III - Premarket Approval.

Submitted by Nidek, Inc. (Walker, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3600 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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

Submission Details

510(k) Number K842892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date October 05, 1984
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 110d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQL Intraocular Lens
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 886.3600
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.