# K061782: Gambro Posiclear

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Services, Inc.
- Decided: Jan 4, 2007 after 192 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have 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) Minntech Corp. Fiberflow Hollow Fiber Capsule Water Filter: named in the summary without a submission number

## Most influential descendants
- K231410: RenaPure Endotoxin Retentive Filter (2023), 0 descendants of its own

## Indications for use
The Gambro Posiclear filter is intended to remove bacteria, endotoxin, and particulate matter from water used for hemodialysis. It is intended for use in dialysis water treatment systems as a final stage of filtration after RO or DI treatment to help control bacteria and endotoxin levels in purified water distribution systems. This filter is not intended as a primary means of water purification for hemodialysis

Source page: https://510kreport.com/device/K061782
Methodology: https://510kreport.com/methodology