Cleared Traditional

INFUSION SET-52-05-1 20 DROPS-MI VOL (K833033) - FDA 510(k) Clearance

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

K833033 · Y · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 213
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
K832284 · Travenol Laboratories, S.A. · Dec 1983
VENOSET MULTI-MED PIGGYBACK W/IVEX-2
K833740 · Abbott Laboratories · Dec 1983
VENOSET MULTI MED DUAL RATE PIGGYBACK
K833741 · Abbott Laboratories · Dec 1983
VENIPUNCTURE VALVE
K832123 · Abbott Laboratories · Aug 1983
SOLUTION ADMIN. SETS W/FLASHBALL
K831311 · Travenol Laboratories, S.A. · Jun 1983
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578 · Abbott Laboratories · Jun 1982