Cleared Traditional

I.V. ADMINISTRATION SET (K832542) - FDA 510(k) Clearance

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

K832542 · Research Industries Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
94d
Days
Class 2
Risk

K832542 is an FDA 510(k) clearance for the I.V. ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Research Industries Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 94 days - within the typical 510(k) review window.

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: 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 Research Industries Corp. devices

Submission Details

510(k) Number K832542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date October 31, 1983
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K832542.
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