Cleared Traditional

K854401 - THE NEW MOBILE TIP MCINTYRE CANNULA

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

K854401 · Microsurgical Technology, Inc. · Ophthalmic device
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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.

View all Microsurgical Technology, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 110d · This submission: 60d
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 K854401.
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
NEEDLES, CANNULAS, CYSTOTOMES
K782169 · Visitec Co. · Feb 1979