Cleared Traditional

INTRAVASCULAR ADMINISTRATION SET (K883764) - FDA 510(k) Clearance

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

K883764 · Device Labs, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
104d
Days
Class 2
Risk

K883764 is an FDA 510(k) clearance for the INTRAVASCULAR ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Device Labs, Inc. (Medway, US). The FDA issued a Cleared decision on December 19, 1988 after a review of 104 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 Device Labs, Inc. devices

Submission Details

510(k) Number K883764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date December 19, 1988
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
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 K883764.
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · Abbott Laboratories · Feb 1989
MODIFIED 7 INCH CONTINUOUS INFUSION SETS
K884102 · Quinton, Inc. · Jan 1989
STANDARD ADMINISTRATION SETS
K885030 · 3M Company · Jan 1989
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638 · Baxter Healthcare Corp · Sep 1988
EXTENDED LIFE INJECTION SITE
K882007 · Baxter Healthcare Corp · Jun 1988
BLOOD/SOLUTION SET W/PRESSURE PUMP
K881321 · Baxter Healthcare Corp · Jun 1988