Cleared Traditional

K863666 - THE SAVER KIT (FDA 510(k) Clearance)

K863666 · Myocure, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
32d
Days
-
Risk

K863666 is an FDA 510(k) clearance for the THE SAVER KIT.

Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on October 20, 1986 after a review of 32 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 Myocure, Inc. devices

Submission Details

510(k) Number K863666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date October 20, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 110d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -