Cleared Traditional

K854401 - THE NEW MOBILE TIP MCINTYRE CANNULA

K854401 is an FDA 510(k) clearance for THE NEW MOBILE TIP MCINTYRE CANNULA, manufactured by Microsurgical Technology, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K854401 · Microsurgical Technology, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
60d
Days
Class 1
Risk

K854401 is an FDA 510(k) clearance for the THE NEW MOBILE TIP MCINTYRE CANNULA. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Microsurgical Technology, Inc. (Kirkland, US). The FDA issued a Cleared decision on December 30, 1985 after a review of 60 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.

FDA 510(k) Submission Details - K854401

510(k) Number K854401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1985
Decision Date December 30, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 110d · This submission: 60d
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 76
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K854401.
IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES
K861545 · Rophae Lens Co., Inc. · May 1986
OPTHALMIC SURGICAL INSTRUMENTS
K860744 · Tridak Division of Indicon, Inc. · Mar 1986
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
K854506 · Storz Instrument Co. · Feb 1986
THE NEW MCINTYRE I.A. HANDPIECE
K854402 · Microsurgical Technology, Inc. · Dec 1985
THE NEW MCINTYRE CANNULA
K853777 · Microsurgical Technology, Inc. · Nov 1985
INFUSION CANNULAM
K852758 · Precision Medical Instruments, Inc. · Aug 1985
K854401 · THE NEW MOBILE TIP MCINTYRE CANNULA
Download PDF Microsurgical Technol…