# K023973: Automed 3200 Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Help Technologies
- Decided: Feb 27, 2003 after 87 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 WalkMedB 300: named in the summary without a submission number
- (no number) McKinley WalkMedB 350: named in the summary without a submission number
- (no number) McKinley WalkMedB PCA: named in the summary without a submission number
- (no number) McKinley WalkMedB IC: named in the summary without a submission number
- (no number) Sorenson Medical, Inc., MicroJectQ 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 3200 ambulatory infusion pump with integrated administration set is 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 3200 infusion pump is 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/K023973
Methodology: https://510kreport.com/methodology