# K945543: Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter Packaged Alone

- Pathway: 510(k) (Traditional)
- Applicant: Intersect Medical Products, Inc.
- Decided: Nov 29, 1994 after 15 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013256: BI-3M Needle-Free Injector System (2001), 1 descendant of its own
- K041280: Human Subcutaneous Injector, Model Hsi 500 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K945543
Methodology: https://510kreport.com/methodology