# K023491: Automed 3300 and 3400 Infusion Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Help Technologies
- Decided: Dec 13, 2002 after 57 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) McKinley WalkMed 300: named in the summary without a submission number
- (no number) McKinley WalkMed 350: named in the summary without a submission number
- (no number) McKinley WalkMed PCA: named in the summary without a submission number
- (no number) McKinley WalkMed IC: named in the summary without a submission number
- (no number) Sorenson Medical, Inc. MicroJect Model 30 pump: named in the summary without a submission number
- (no number) Sorenson Medical, Inc. Model 200 Pump: named in the summary without a submission number
- (no number) Sorenson Medical, Inc. Model PCA Pump: named in the summary without a submission number
- (no number) Sorenson Medical, Inc. Model PCEA Pump: named in the summary without a submission number
- (no number) Stryker Instruments Pain Pump II: named in the summary without a submission number
- (no number) I-Flow PainBuster Infusion Kit: named in the summary without a submission number

## Indications for use
The AutoMed 3300 and 3400 ambulatory infusion pumps and dedicated administration sets and accessories are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. The AutoMed systems are also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

Source page: https://510kreport.com/device/K023491
Methodology: https://510kreport.com/methodology