# K852645: Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Dec 9, 1985 after 171 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has 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
- K972284: Fluid Management System (1997), 9 descendants of its own
- K032674: Belmont Fluid Management System, Model FMS2000 (2003), 5 descendants of its own
- K992672: Belmont Fluid Management System (FMS2000) (1999), 3 descendants of its own
- K141654: The Belmont Rapid Infuser (2014), 2 descendants of its own
- K032778: Large Volume Fluid Reservoir (2003), 2 descendants of its own

Source page: https://510kreport.com/device/K852645
Methodology: https://510kreport.com/methodology