# K000266: Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation

- Pathway: 510(k) (Traditional)
- Applicant: Primary Care Solutions, Inc.
- Decided: Jul 12, 2001 after 531 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation (2008), 7 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own
- K213514: Spectricept Skin and Wound Cleanser (2023), 1 descendant of its own
- K090848: Premier Sterile Saline Wound Wash, Models 210 ML, WWM (2009), 1 descendant of its own

Source page: https://510kreport.com/device/K000266
Methodology: https://510kreport.com/methodology