Cleared Traditional

ALCON FLUID INJECTOR (K882723) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882723 · Alcon Laboratories · General Hospital
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Nov 1988
Decision
130d
Days
Class 2
Risk

K882723 is an FDA 510(k) clearance for the ALCON FLUID INJECTOR. Classified as Actuator, Syringe, Injector Type (product code DQF), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on November 8, 1988 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1670 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcon Laboratories devices

Submission Details

510(k) Number K882723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1988
Decision Date November 08, 1988
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQF Actuator, Syringe, Injector Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.