# K841153: Adaptor HR-3000 Reuse

- Pathway: 510(k) (Traditional)
- Applicant: Colorado Medical, Inc.
- Decided: Jul 16, 1984 after 119 days
- Product code: LIF (Dialyzer Reprocessing System)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 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
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (2002), 12 descendants of its own
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K043436: Nxstage Dialysate Preparation Module, Model NX0269 (2005), 5 descendants of its own
- K060296: Nxstage Dialysate Preparation Module (2006), 3 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own

Source page: https://510kreport.com/device/K841153
Methodology: https://510kreport.com/methodology