# K910425: Large Volume Elastomeric Infusion Device Attach.

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 1, 1991 after 60 days
- Product code: FRN (Pump, Infusion)
- 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K971362: Personal Infusor (1997), 1 descendant of its own
- K990208: Personal Infusor with Drug Disposal Septal Port (1999), 0 descendants of its own

## Recalls of this device
- Jun 7, 2013 · Class II · Z-1604-2013: 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
- Jun 7, 2013 · Class II · Z-1605-2013: 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/K910425
Methodology: https://510kreport.com/methodology