Cleared Traditional

K023973 - AUTOMED 3200 INFUSION PUMP

K023973 is an FDA 510(k) clearance for AUTOMED 3200 INFUSION PUMP, 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 87-day FDA review.

K023973 · Help Technologies · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
87d
Days
Class 2
Risk

K023973 is an FDA 510(k) clearance for the AUTOMED 3200 INFUSION PUMP. 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 February 27, 2003 after a review of 87 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 - K023973

510(k) Number K023973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2002
Decision Date February 27, 2003
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 K023973.
VISTA BASIC WITH FM SYSTEM
K023189 · B.Braun Medical, Inc. · Mar 2003
FENESTRATED INFUSION CATHETER
K024190 · Promedic, Inc. · Mar 2003
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