# K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation

- Pathway: 510(k) (Traditional)
- Applicant: Primary Care Solutions, Inc.
- Decided: Oct 9, 2008 after 56 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000265 (2001). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000265: Primary Care Solutions Sterile Water Device Irrigation, Primary Care Solutions, Inc. (2001) Summary page 1.
- K000266: Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation, Primary Care Solutions, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K243875: Spectricept Skin and Wound Cleanser (2025), 0 descendants of its own

## Indications for use
Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement

Source page: https://510kreport.com/device/K082330
Methodology: https://510kreport.com/methodology