Cleared Traditional

K861545 - IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES

K861545 is an FDA 510(k) clearance for IRRIGATION/ASPIRATION CANNULAS, manufactured by Rophae Lens Co., Inc.. The device is a Class 1 Ophthalmic device with 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

FDA 510(k) Submission Details - K861545

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.

HMX Device Classification - Class 1, General Controls

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 49
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K861545.
LOOK IRRIGATING/ASPIRATING CANNULAS
K870436 · Look, Inc. · Feb 1987
LOOK IRRIGATING CANNULAS
K870438 · Look, Inc. · Feb 1987
LOOK CORTEX EXTRACTORS
K870441 · Look, Inc. · Feb 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
INFUSION CANNULA
K831192 · Medical Instrument Development Laboratories, Inc. · Jun 1983