Cleared Traditional

K833033 - INFUSION SET-52-05-1 20 DROPS-MI VOL

K833033 is the FDA 510(k) clearance for INFUSION SET-52-05-1 20 DROPS-MI VOL by Y. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K833033 · Y · General Hospital
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Nov 1983
Decision
61d
Days
Class 2
Risk

K833033 is an FDA 510(k) clearance for the INFUSION SET-52-05-1 20 DROPS-MI VOL. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Y (Mchenry, US). The FDA issued a Cleared decision on November 7, 1983 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Y devices

Submission Details

510(k) Number K833033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1983
Decision Date November 07, 1983
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 470
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K833033.
SOLUTION ADMIN. SET 2C9096 W/10 PVC
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VENOSET MULTI-MED PIGGYBACK W/IVEX-2
K833740 · Abbott Laboratories · Dec 1983
VENOSET MULTI MED DUAL RATE PIGGYBACK
K833741 · Abbott Laboratories · Dec 1983
UNIVERSAL VENTED & NON/VOLUME INFUS-
K833034 · Y · Nov 1983
INTRAVASCULAR ADMINISTRATION SET
K833030 · Gish Biomedical, Inc. · Nov 1983
INFUSION SETS #'S 124 & 142 PERSONAL
K831445 · Pacesetter Systems · Sep 1983