Cleared Traditional

ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR (K883609) - 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
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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.

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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 233
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K883609.
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
BASAL/BOLUS INFUSORS
K884505 · Baxter Healthcare Corp · Jul 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · Abbott Laboratories · Apr 1989
LIFECARE MICRO PUMP
K883796 · Abbott Laboratories · Feb 1989
FLO-GARD VP
K884014 · Baxter Healthcare Corp · Dec 1988
BARD INFUSOR PUMP
K883577 · C.R. Bard, Inc. · Nov 1988