Cleared Traditional

K803302 - PREHEPARINZED SYRINGE

K803302 is the FDA 510(k) clearance for PREHEPARINZED SYRINGE by The University of Chicago. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K803302 · The University of Chicago · General Hospital
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Apr 1981
Decision
99d
Days
Class 2
Risk

K803302 is an FDA 510(k) clearance for the PREHEPARINZED SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by The University of Chicago (Mchenry, US). The FDA issued a Cleared decision on April 8, 1981 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 The University of Chicago devices

Submission Details

510(k) Number K803302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1980
Decision Date April 08, 1981
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.

Regulatory Peers - FMF Syringe, Piston

All 312
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K803302.
PREFILLED PULSATOR SYRINGE
K811009 · Concord Laboratories, Inc. · Jun 1981
PREFILLED PULSATOR SYRINGE
K810995 · Concord Laboratories, Inc. · May 1981
PISTON SYRINGE
K811065 · Sherwood Medical Co. · May 1981
CONTROL SYRINGE
K801430 · Abco Dealers, Inc. · Jul 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · Burron Medical Products, Inc. · Jun 1980
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033 · Medline Industries, Inc. · Nov 1979