Cleared Traditional

K023491 - AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM

K023491 is an FDA 510(k) clearance for AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM, manufactured by Help Technologies. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K023491 · Help Technologies · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
57d
Days
Class 2
Risk

K023491 is an FDA 510(k) clearance for the AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Help Technologies (Dana Point, US). The FDA issued a Cleared decision on December 13, 2002 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Help Technologies devices

FDA 510(k) Submission Details - K023491

510(k) Number K023491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2002
Decision Date December 13, 2002
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
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 561
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K023491.
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K023083 · Mettler Electronics Corp. · Feb 2003
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
K023264 · Alaris Medical Systems, Inc. · Dec 2002
PARAGON INFUSION SYSTEM WITH BOLUS
K023827 · I-Flow Corp. · Dec 2002
SOAKER CATHETER
K022869 · I-Flow Corp. · Sep 2002
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
K021988 · Medrad, Inc. · Aug 2002