Cleared Traditional

MODIFIED MYDRIATIC SPECTACLE (K854140) - FDA 510(k) Clearance

K854140 · La Rue Optical · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
68d
Days
-
Risk

K854140 is an FDA 510(k) clearance for the MODIFIED MYDRIATIC SPECTACLE.

Submitted by La Rue Optical (Dover, US). The FDA issued a Cleared decision on December 17, 1985 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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.

View all La Rue Optical devices

Submission Details

510(k) Number K854140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1985
Decision Date December 17, 1985
Days to Decision 68 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 110d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -