Cleared Traditional

DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0 (K873853) - FDA 510(k) Clearance

Class I Ophthalmic device.

K873853 · Advanced Surgical Products, Inc. · Ophthalmic device
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Mar 1988
Decision
167d
Days
Class 1
Risk

K873853 is an FDA 510(k) clearance for the DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on March 7, 1988 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Surgical Products, Inc. devices

Submission Details

510(k) Number K873853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1987
Decision Date March 07, 1988
Days to Decision 167 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 110d · This submission: 167d
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.