Cleared Traditional

K811455 - ANIS GUIDING CANNULA

K811455 is an FDA 510(k) clearance for ANIS GUIDING CANNULA, manufactured by American V. Mueller. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K811455 · American V. Mueller · Ophthalmic device
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Jun 1981
Decision
25d
Days
Class 1
Risk

K811455 is an FDA 510(k) clearance for the ANIS GUIDING CANNULA. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by American V. Mueller (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 25 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 - K811455

510(k) Number K811455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date June 16, 1981
Days to Decision 25 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
85d faster than avg
Panel avg: 110d · This submission: 25d
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 K811455.
NLD IMPLANT SET
K813314 · Design Research Assoc., Inc. · Feb 1982
OMS INFUSION CANNULA ASSEMBLE
K813481 · Optical Micro Systems, Inc. · Jan 1982
KOI LACRIMAL INTUBATION SYSTEM
K812010 · Koi, Inc. · Jul 1981
MAY ILLUMINATED/INFUSION PIC
K801411 · Cooper Medical Devices Corp. · Jul 1980
X-PAK
K791917 · Contemporary Surgical Systems, Inc. · Oct 1979
CANNULA'S CAT #'S 6636, 6624, 6625
K791982 · Edward Weck, Inc. · Oct 1979
K811455 · ANIS GUIDING CANNULA
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