Cleared Traditional

K832542 - I.V. ADMINISTRATION SET

K832542 is an FDA 510(k) clearance for I.V. ADMINISTRATION SET, manufactured by Research Industries Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

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

FDA 510(k) Submission Details - K832542

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.

FPA Device Classification - Class 2, Special Controls

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 824
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K832542.
INFUSION SET-52-05-1 20 DROPS-MI VOL
K833033 · Y · Nov 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
STERILE IV SET 4 SIZES
K832329 · Abco Dealers, Inc. · Aug 1983
VENIPUNCTURE VALVE
K832123 · Abbott Laboratories · Aug 1983