Cleared Traditional

K882723 - ALCON FLUID INJECTOR

K882723 is an FDA 510(k) clearance for ALCON FLUID INJECTOR, manufactured by Alcon Laboratories. The device is a Class 2 General Hospital device with product code DQF cleared through the Traditional 510(k) pathway after a 130-day FDA review.

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

FDA 510(k) Submission Details - K882723

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
Combination Product No
PCCP Authorized No
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.

DQF Device Classification - Class 2, Special Controls

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.