# K082182: AP 34 Multi-Therapy Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Q-Core, Ltd.
- Decided: Aug 15, 2008 after 14 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: 2 generations back to K021480 (2002). 4 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960826: Cadd-Prizm Model 6100 Pump, Sims Deltec, Inc. (1996) Summary page 2.
- K031749: Bodyguard Infusion System, Caesarea Medical Electronics, Ltd. (2003) Summary page 2.
- K041490: IV Administration Sets with Ultrablock UV-Resistant Tubing, B.Braun Medical, Inc. (2004) Summary page 2.

## Most influential descendants
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own
- K141389: Sapphire Infusion Pump (2014), 3 descendants of its own
- K161667: Sapphire Infusion Pump (2017), 2 descendants of its own
- K192860: Sapphire Infusion Pump, Sapphire administration sets (2020), 1 descendant of its own
- K213744: Avoset Infusion Pump System (2023), 0 descendants of its own

## Indications for use
The AP 34 is a multi-therapy infusion pump system designed for the volumetric infusion of medication and nutritional fluids to patients in the hospital, homecare and outpatient environments in the following delivery modes: CONTINUOUS; INTERMITTENT; PCA (Patient Control Analgesia) and TPN (Total Parenteral Nutrition). The AP 34 is not intended for the following use or substances: * Delivery of blood or cellular blood products * Intra-cardiac use. The AP 34 infusion pump includes the following accessories: * Bolus cable * 0Q--Core approved AC/DC adaptor (external)] * Cradle (optional) and power cable for cradle * Rechargeable battery pack for pump * PCA cover box * Communication cables The dedicated Q-Core Administration Sets for the AP 34 infusion pump are intended for single-patient use only. The AP 34 infusion pump system is for prescription use only.

Source page: https://510kreport.com/device/K082182
Methodology: https://510kreport.com/methodology