Cleared Traditional

K832912 - GELENDER VACUUM FIXATION RING SYS

K832912 is an FDA 510(k) clearance for GELENDER VACUUM FIXATION RING SYS, manufactured by Miami Eye Technology, Inc.. The device is a Class 1 Ophthalmic device with product code HNH cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K832912 · Miami Eye Technology, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
134d
Days
Class 1
Risk

K832912 is an FDA 510(k) clearance for the GELENDER VACUUM FIXATION RING SYS. Classified as Ring, Ophthalmic (flieringa) (product code HNH), Class I - General Controls.

Submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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.

View all Miami Eye Technology, Inc. devices

FDA 510(k) Submission Details - K832912

510(k) Number K832912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date January 10, 1984
Days to Decision 134 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 110d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

HNH Device Classification - Class 1, General Controls

Product Code HNH Ring, Ophthalmic (flieringa)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.