# K920697: Dextrolyte II Peritoneal Dialysis 48-3029-7 Clamp

- Pathway: 510(k) (Traditional)
- Applicant: National Medical Care, Medical Products Div., Inc.
- Decided: Sep 21, 1992 after 220 days
- Product code: FJH (Dialyzer, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5830
- 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.
1 of 3 devices in its family (counting itself) has 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
- K173593: stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch (2018), 1 descendant of its own
- K250404: stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K920697
Methodology: https://510kreport.com/methodology