Cleared Traditional

K883609 - ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR (FDA 510(k) Clearance)

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

K883609 · Squibb Diagnostics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
235d
Days
Class 2
Risk

K883609 is an FDA 510(k) clearance for the ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Squibb Diagnostics (New Brunswick, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 235 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.5725 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Squibb Diagnostics devices

Submission Details

510(k) Number K883609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1988
Decision Date April 14, 1989
Days to Decision 235 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 107d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 Radiology devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 847
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K883609.
FreedomEdge Infusion System
K252015 · Koru Medical Systems, Inc. · Jan 2026
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · Baxter Healthcare Corporation · Jul 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · Baxter Healthcare Corporation · Jul 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · Iradimed Corporation · May 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · Carefusion 303, Inc. · Apr 2025
Plum Solo™ Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025