Cleared Traditional

K861545 - IRRIGATION/ASPIRATION CANNULAS

K861545 is the FDA 510(k) clearance for IRRIGATION/ASPIRATION CANNULAS by Rophae Lens Co., Inc.. It is a Class 1 Ophthalmic device (product code HMX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K861545 · Rophae Lens Co., Inc. · Ophthalmic device
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May 1986
Decision
34d
Days
Class 1
Risk

K861545 is an FDA 510(k) clearance for the IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Rophae Lens Co., Inc. (St. Petersburg, US). The FDA issued a Cleared decision on May 28, 1986 after a review of 34 days - a notably fast clearance cycle.

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: 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 Rophae Lens Co., Inc. devices

Submission Details

510(k) Number K861545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date May 28, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 110d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMX Cannula, Ophthalmic
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.

Regulatory Peers - HMX Cannula, Ophthalmic

All 38
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K861545.
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
K873853 · Advanced Surgical Products, Inc. · Mar 1988
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA
K871605 · Advanced Surgical Products, Inc. · Jun 1987
OPHTHALMIC CANNULA
K872151 · Pharmacia, Inc. · Jun 1987
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
K854506 · Storz Instrument Co. · Feb 1986
SITE ANTERIOR CAPSULOTOMER
K843039 · Chiron Vision Corp. · Nov 1984
CANNULA'S CAT #'S 6636, 6624, 6625
K791982 · Edward Weck, Inc. · Oct 1979