# K974332: Variable Pressure Syringe Pump

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Dec 29, 1998 after 406 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
Longest line of descent: 1 generation back to K940147 (1994). 1 ancestor in all.
22 later devices descend from it; 1 cites it directly.
7 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940147: Auto Syringe AS40A Infusion Pump, Baxter Corp. (1994) Summary page 1.

## Most influential descendants
- K023264: Medley Syringe Pump Module System, Model 8110 (2002), 21 descendants of its own
- K053554: Compuflo (2006), 6 descendants of its own
- K101194: Navigator Delivery System (or Navigator DS) Model: Nav-010 (2011), 5 descendants of its own
- K112067: Navigator Delivery System (Navigator DS) (2011), 4 descendants of its own
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS) (2011), 4 descendants of its own

## Indications for use
The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application. ALARIS Medical Systems’ policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent with this policy, we would contraindicate drugs and/or fluids as appropriate for the P7000. No such contraindications have been identified. The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.

Source page: https://510kreport.com/device/K974332
Methodology: https://510kreport.com/methodology