# K940147: Auto Syringe AS40A Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Corp.
- Decided: Apr 15, 1994 after 94 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974332: Variable Pressure Syringe Pump (1998), 22 descendants of its own
- 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

## Recalls of this device
- Feb 8, 2006 · Not classified · Z-0599-06: The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

Source page: https://510kreport.com/device/K940147
Methodology: https://510kreport.com/methodology