# K982102: Singleday Infusor 2 ML/HR (Elastomeric Infusion Device) Model, Infusor SV 5 ML/HR (Elastomeric Infusion Device) Model CY

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 4, 1998 after 81 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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.
6 later devices descend from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Singleday Infusor: named in the summary without a submission number
- (no number) Multiday Infusor: named in the summary without a submission number
- (no number) Infusor SV: named in the summary without a submission number
- (no number) Seven Day Infusor: named in the summary without a submission number
- (no number) 2 Day Infusor: named in the summary without a submission number

## Most influential descendants
- K062457: Infusor Small Volume Elastomeric Infusion Devices (2006), 5 descendants of its own
- 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

## Recalls of this device
- Mar 15, 2011 · Not classified · Z-2146-2011: Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.

## 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/K982102
Methodology: https://510kreport.com/methodology