Cleared Traditional

K842568 - RADIONUCLIDE INFUSION SYSTEM

K842568 is an FDA 510(k) clearance for RADIONUCLIDE INFUSION SYSTEM, manufactured by Squibb Diagnostics. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K842568 · Squibb Diagnostics · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
109d
Days
Class 2
Risk

K842568 is an FDA 510(k) clearance for the RADIONUCLIDE INFUSION SYSTEM. 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 October 19, 1984 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Squibb Diagnostics devices

FDA 510(k) Submission Details - K842568

510(k) Number K842568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date October 19, 1984
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 617
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K842568.
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · Intermedics, Inc. · Nov 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · Intermedics, Inc. · Oct 1984
ENTERAL FEEDING PUMP 14-800 SERIES
K843168 · Biosearch Medical Products, Inc. · Oct 1984
MODULAR VOLUMETRIC INFUSION PUMP SYS
K843274 · American Edwards Laboratories · Oct 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · Sherwood Medical Co. · Aug 1984
IVAC 3080 ENTERAL FEEDING PUMP
K842027 · Y · Jul 1984