# K971362: Personal Infusor

- Pathway: 510(k) (Traditional)
- Applicant: Science Incorporated
- Decided: Dec 4, 1997 after 237 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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
Longest line of descent: 1 generation back to K896546 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896546: Homepump (Disp. Elastomeric Infusion Device), Block Medical, Inc. (1990) Summary page 1.
- K910425: Large Volume Elastomeric Infusion Device Attach., Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K990208: Personal Infusor with Drug Disposal Septal Port (1999), 0 descendants of its own

## Indications for use
The Science Incorporated Personal Infusor is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation. The flexibility offered by the Personal Infusor will enable physicians to choose from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients.

Source page: https://510kreport.com/device/K971362
Methodology: https://510kreport.com/methodology