# K062457: Infusor Small Volume Elastomeric Infusion Devices

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Sep 21, 2006 after 29 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802820 (1980). 7 ancestors in all.
5 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)
- K802820: Travenol 24 HR. Infusor (Elastomeric PP), Travenol Laboratories, S.A. (1980) Summary page 2.
- K905778: Epidural Indication for Baxter Infusors Attachment, Baxter Healthcare Corp (1991) Summary page 2.
- K982102: Singleday Infusor 2 ML/HR (Elastomeric Infusion Device) Model, Infusor SV 5 ML/HR (Elastomeric Infusion Device) Model CY, Baxter Healthcare Corp (1998) Summary page 2.
- K853881: The Travenol 5 ML/HR Infusor, Travenol Laboratories, S.A. (1985) Summary page 2.
- K842479: I.V. Teamate, Medical Delivery Systems (1984) Summary page 2.
- K870242: Intermate (TM), Infusion Systems Corp. (1987) Summary page 2.
- K842905: Travenol Multiday Infusor 2C1080, Travenol Laboratories, S.A. (1985) Summary page 2.

## Most influential descendants
- K081905: Accuflow and Accuflux Elastomeric Infusion Pump (2008), 4 descendants of its own
- K151650: SMARTez elastomeric infusion pump (2016), 3 descendants of its own
- K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series) (2026), 0 descendants of its own
- K240624: InfuLife (2024), 0 descendants of its own
- K242152: SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (2024), 0 descendants of its own

## Recalls of this device
- Jun 7, 2013 · Class II · Z-1609-2013: Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
- Nov 29, 2007 · Not classified · Z-0588-2008: Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.

## Indications for use
Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.

Source page: https://510kreport.com/device/K062457
Methodology: https://510kreport.com/methodology