# K943664: Intermate XLV Elastomeric Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 3, 1994 after 98 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jun 7, 2013 · Class II · Z-1603-2013: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvemen

Source page: https://510kreport.com/device/K943664
Methodology: https://510kreport.com/methodology